| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. | Stryker GmbH | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: GEM Premier 5000 with IQM2 Model/Catalog Number: 00024019255 and GEM Premier 7000 with iQM3 Model/ | Instrumentation Laboratory | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass | Medtronic Perfusion Systems | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: IQon Spectral CT IQon Spectral CT Upgrades | PHILIPS MEDICAL SYSTEMS | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3 | Permobil Inc | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga | Argon Medical Devices, Inc | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. | Stryker GmbH | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683 | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Numbe | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12 | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Numb | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Power Over Fiber Base Module | Terex Utilities | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. | Stryker GmbH | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. | Stryker GmbH | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 0087 | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 po | Instrumentation Laboratory | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: M5 Corpus Power Wheelchair REF,120032 | Permobil Inc | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass a | Medtronic Perfusion Systems | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or int | ResMed Ltd. | Class I | N/A |
| 2026-08-05 | FDA Device | FDA Recall: OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm (IsoTis Brand), R | IsoTis OrthoBiologics, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass a | Medtronic Perfusion Systems | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass | Medtronic Perfusion Systems | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brill | PHILIPS MEDICAL SYSTEMS | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic Star Off Hand | Medical Action Industries, Inc. 306 | Class I | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, P | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Po | Instrumentation Laboratory | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10 | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. | Stryker GmbH | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model/Catalog Number | Instrumentation Laboratory | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return ca | Medtronic Perfusion Systems | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. | Stryker GmbH | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. | Stryker GmbH | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Po | Instrumentation Laboratory | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Up | PHILIPS MEDICAL SYSTEMS | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Ep | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620 | Argon Medical Devices, Inc | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 p | Instrumentation Laboratory | Class II | N/A |
| 2026-08-05 | FDA Device | FDA Recall: EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial r | Medtronic Perfusion Systems | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the c | Boston Scientific Corporation | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the cham | Boston Scientific Corporation | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Car | Boston Scientific Corporation | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 | Olympus Corporation of the Americas | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-b | Emano Metrics, Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation C | Boston Scientific Corporation | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the cham | Boston Scientific Corporation | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: 3mensio Workstation (Vascular Fenestrated) software | PIE Medical Imaging B.V. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G | Medline Industries, LP | Class I | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Ventriculostomy Kit, REF: 46154 | Medtronic Neurosurgery | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter | Boston Scientific Corporation | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit. | AVID Medical, Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: The intended use is to be paired with a weapon for aiming purposes. | Wilcox Industries Corp. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT | Prismatik Dentalcraft, Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397P | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and d | ICU Medical Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU D | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T | Medline Industries, LP | Class I | N/A |
| 2026-07-29 | FDA Device | FDA Recall: SnapshotGLO Wound Imaging Device, Model KB100, KB100AA. | KENT IMAGING, INC. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for profe | Ferno-Washington Inc | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, Medlin | Medline Industries, LP | Class I | N/A |
| 2026-07-29 | FDA Device | FDA Recall: SeaSpine Polyaxial Head REF Number: 41-3010 | SEASPINE ORTHOPEDICS CORPORATION | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOTAL KN | Medline Industries, LP | Class I | N/A |
| 2026-07-29 | FDA Device | FDA Recall: MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N | Medline Industries, LP | Class I | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU DYNJ39590O; 2) S | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF PED2-300-12 | Micro Therapeutics, Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit. | AVID Medical, Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System | Alphatec Spine, Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm | Paragon 28, Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endosco | Karl Storz Endoscopy | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF PED2-300-20 | Micro Therapeutics, Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT | Penumbra, Inc. | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit d | Olympus Corporation of the Americas | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological | Boston Scientific Corporation | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A: 2) | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba | Medline Industries, LP | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Car | Boston Scientific Corporation | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers | Boston Scientific Corporation | Class II | N/A |
| 2026-07-29 | FDA Device | FDA Recall: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16, 18, 20) 5cc ba | Medline Industries, LP | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introd | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf | Oscor Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267 | Medline Industries, LP | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf | Oscor Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Bone Marrow Tray, REF: CB0033TL; CB0355TLA | Argon Medical Devices, Inc | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Optima XR240amx, Mobile Digital Radiographic System | GE Medical Systems, LLC | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL | Argon Medical Devices, Inc | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary bypass vascul | Medtronic Perfusion Systems | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. hear | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introd | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Papablic Replacement Brush Heads. Model Number: Papablic18B | Papablic Inc | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Papablic Replacement Brush Heads. Model Number: PAPA317AA. | Papablic Inc | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders | Daavlin Distributing Company | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Arterial Line Kit 20ga x 6, REF: 400115A | Argon Medical Devices, Inc | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testoster | Tosoh Bioscience Inc | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma ext | Orthofix U.S. LLC | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: General Biospy Tray, REF: GUTS1000 | Argon Medical Devices, Inc | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Optima XR220amx, Mobile Digital-Ready Radiographic System | GE Medical Systems, LLC | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Rapid Refill Continuous Injection System, UPN M00566001 | Boston Scientific Corporation | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product C | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external fixation devi | Orthofix U.S. LLC | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders | Daavlin Distributing Company | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Optima XR200amx, Mobile Digital-Ready Radiographic System | GE Medical Systems, LLC | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. hear | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr I | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 | Intuitive Surgical, Inc. | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A | Argon Medical Devices, Inc | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Pro | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular | Argon Medical Devices, Inc | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral orthopedic/trauma exte | Orthofix U.S. LLC | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf | Oscor Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, S | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a | Maquet Cardiovascular, LLC | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052 | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders | Daavlin Distributing Company | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J | Medline Industries, LP | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma exter | Orthofix U.S. LLC | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump | ICU Medical, Inc. | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer P | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Brand Name: Rio" II Product Name: Rio" II Nasal Pillows Interface Model/Catalog Number: RII1001 (S | 3B Medical, Inc. | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; | ICU Medical, Inc. | Class II | N/A |
| 2026-07-22 | FDA Device | FDA Recall: ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer | Abiomed, Inc. | Class I | N/A |
| 2026-07-22 | FDA Device | FDA Recall: Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010; Cardiopulmonary bypass | Medtronic Perfusion Systems | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PA | Medline Industries, LP | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading | Elekta, Inc. | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: OmniTract Surgical Retractor System, which includes 633 of the firm s product codes. | Integra LifeSciences Corp. (NeuroSciences) | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Descr | Elekta, Inc. | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: VITEK 2 AST-N447 TEST KIT Product reference 424620 | Biomerieux Inc | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341- | Encore Medical, LP | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125A | Medline Industries, LP | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R | ConvaTec, Inc | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. | Siemens Healthcare Diagnostics, Inc. | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. | Fresenius Medical Care Holdings, Inc. | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRAC | Boston Scientific Neuromodulation Corporation | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 10 | Think Surgical, Inc. | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORE | WALLAC OY | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Numbe | CMR SURGICAL LIMITED | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is inten | Elekta, Inc. | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2) ACCESSORY KIT, Mo | Medline Industries, LP | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342- | Encore Medical, LP | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscop | Olympus Corporation of the Americas | Class II | N/A |
| 2026-07-15 | FDA Device | FDA Recall: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, | Klowen Braces | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: | BD SWITZERLAND SARL | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Pro Wireguided 6-8mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OPE | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Wireguided 18-20mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH CENTRAL L | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699A | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; O | Baxter Healthcare Corporation | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: ARTIS icono ceiling. Model Number: 11328100. | Siemens Medical Solutions USA, Inc | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: 5605150 Power-Trialysis Short-Term Straight Dialysis Catheter 13 Fr Triple-Lumen UDI-DI Code: 00801 | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit | Windstone Medical Packaging, Inc. | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590 | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 ( | Insulet Corporation | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04 | Medacta Usa Inc | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Pro Wireguided 18-20mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with | Zimmer Surgical Inc | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit | Windstone Medical Packaging, Inc. | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley s | Laborie Medical Technologies Corp | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medi | Medline Industries, LP | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922A | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2) CIRCUMCIS | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND GUIDED IV SE | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: ARTIS icono biplane. Model Number: 11327600. | Siemens Medical Solutions USA, Inc | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medtronic Harmony Delivery Catheter System | Medtronic Heart Valves Division | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Pro Wireguided 8-10mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Radius VSM Disposable NIBP Cuff, REF: 4825, 4826 | Masimo Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Acc | Accuray Incorporated | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYN | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptio | DEPUY (IRELAND) | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidlin | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Wireguided 6-8mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Grosh | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M084 | Baxter Healthcare Corporation | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product description | DEPUY (IRELAND) | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-5 | Insulet Corporation | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C; 2) STD, IN | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose wi | Zimmer Surgical Inc | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit | Windstone Medical Packaging, Inc. | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215 | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side | Baxter Healthcare Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS98 | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Acc | Accuray Incorporated | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter st | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with HAMILTON-C1, HAMILTON- | Hamilton Medical AG | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2) Universa | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2) PAIN1470A | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United | W L Gore & Associates, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Cod | Covidien LLC | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Pro Wireguided 15-18mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: 1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Cathet | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Pro Wireguided 10-12mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: RayCare 2024A SP4. Oncology Information Systems. | RAYSEARCH LABORATORIES AB | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2) CONTINUOUS EPI | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 P | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Proven | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710 | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CK000727 PowerMidline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741138478 CK000729 PowerMidli | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-622 | Insulet Corporation | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557 | Carl Zeiss Meditec AG | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Pro Wireguided 12-15mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST BIOPSY PACK, | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE INSERTION TRAY, M | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksor | TELEFLEX LLC | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC MAJOR DYNJ901328G | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609 CK000566 Poly Midl | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: RayCare 2024A SP1. Oncology Information Systems. | RAYSEARCH LABORATORIES AB | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460 | Remel, Inc | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; | Baxter Healthcare Corporation | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: IntelliCuff, Portable automatic cuff pressure controller REF: 951001 | Hamilton Medical AG | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995; 2) TRIP | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Wireguided 10-12mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience ki | Windstone Medical Packaging, Inc. | Class I | N/A |
| 2026-07-08 | FDA Device | FDA Recall: ARTIS icono floor. Model Number: 11327700. | Siemens Medical Solutions USA, Inc | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Wireguided 15-18mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Wireguided 12-15mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: CRE Wireguided 8-10mm 240cm | Boston Scientific Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM SET UP D | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B9604 Syringe, Pisto | Mentor Texas LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: ARTIS icono ceiling. Model Number: 11328100. | Siemens Medical Solutions USA, Inc | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060 | Medela Inc | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI C | Bard Access Systems, Inc. | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Radius VSM ECG pre-connected Set, REF: 4842, 4695 | Masimo Corporation | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN CABG DYNJ90585 | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Medline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK CTX DYN | Medline Industries, LP | Class II | N/A |
| 2026-07-08 | FDA Device | FDA Recall: Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473 | Baxter Healthcare Corporation | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device | Boston Scientific Corporation | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.125.NVG.H1; drills, burrs, trephines & accesso | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. FTMC C-SECTION TR | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augme | Zimmer, Inc. | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. | Abiomed, Inc. | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, trephines & accessor | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2) DYNJ9055 | Medline Industries, LP | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310 | PFM MEDICAL INC. | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444 | Zimmer, Inc. | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, burrs, trephines & ac | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651 | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAM PACK-LF | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070- | Acumed LLC | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: | Zimmer, Inc. | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CENTRAL LINE TRAY | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. MAJOR BASIN SET | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, trephines & accessor | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. PICC LINEPACK (PC | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System | GE Medical Systems SCS | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Octopus Evolution Tissue Stabilizer, Model TS2000 | Medtronic Perfusion Systems | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Philips Avalon Fetal Monitor, FM 30 Part numberM2703A | Philips North America Llc | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser. | IPG Medical Corporation | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 40 mm, Long, Model/Catalog Number: 40.125.NVG.U1; drills, burrs, trephines & accessori | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, burrs, trephines & ac | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs, trephines & accesso | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.U1; drills, burrs, trephines & accessor | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number | Zimmer, Inc. | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.H1; drills, burrs, trephines & ac | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Numbe | Zimmer, Inc. | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descript | Philips North America Llc | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Intro | Abiomed, Inc. | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2) CENTRAL | Medline Industries, LP | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (s | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO PACK DYN | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: TMJ Bilateral Implants, REF: CHG020 | TMJ Solutions Inc | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BOD | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART, Model Numb | Medline Industries, LP | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.U1; drills, burrs, trephines & access | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. DR G'S BREAST PAC | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.U1; drills, burrs, trephines & accessor | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. KIT NEURO CSTM | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2) OPEN HEAR | Medline Industries, LP | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001 | Ventec Life Systems, Inc. | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 3.0 mm, Extendable, Model/Catalog Number: 30.000.SEE.U2; drills, burrs, trephines & ac | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.U1; drills, burrs, trephines & accesso | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CRANIOTOMY PACK-L | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A | Philips North America Llc | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs, trephines & accesso | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.H1; drills, burrs, trephines & accesso | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIOGRAPHY PACK- | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.140.SHD.H1; drills, burrs, trephines & accessor | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Octopus Evolution AS Tissue Stabilizer, Model TS2500 | Medtronic Perfusion Systems | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Intro | Abiomed, Inc. | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476 | Zimmer, Inc. | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. | Abiomed, Inc. | Class I | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ABDOMINAL VASCULA | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor | Dexcom, Inc. | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 5.4 mm, Extendable, Model/Catalog Number: 54.000.SEE.U1; drills, burrs, trephines & ac | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: INZONE DETACHMENT SYSTEM, REF: M00345100950 | Stryker Neurovascular | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Da Vinci ASSY, PSS, SP1098, Part Number: 380601 | Intuitive Surgical, Inc. | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Octopus 4 Tissue Stabilizer, Model 29400 | Medtronic Perfusion Systems | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs, trephines & accesso | SURGIFY MEDICAL OY | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. BARIATRIC DYNJ90 | Medline Industries, LP | Class II | N/A |
| 2026-07-01 | FDA Device | FDA Recall: Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO CATH COMBIN | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ5 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: ADULT TRACHEOSTOMY TUBE INSERT, ASC T&A, CONWAY T&A SI | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ALYON Surgical Lighting System | Steris Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4 Stylet: 3L 6FR | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 F | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X 20 CM AGB | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: BASIC EYE DYNJ905154I TUBAL LIGATION CDS CDS760053K | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kit: KIT: DRESSING CHANGE PED DYNDC3359 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Ca | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubat | GE Medical Systems, LLC | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY, D AND C PACK, MAD D & C, VPH | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 | Smith & Nephew, Inc. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-4455 | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: DISCECTOMY PACK DYNJ86476B EAR DYNJ81460C DYNJ900004J DYNJ901779 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING P | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12- | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Ca | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 14 Fr, 1000mL, Medline Pr | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C | AMD Medicom Inc. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS, Medline Kit Number/SKU CDS98377 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ8 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. C | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models | GE Medical Systems, LLC | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ9041 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Centurion convenience kits: CENTRAL LINE DRESSING SV43 FCP DYNDC2356B DIALYSIS CATHETER MAINT | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Ster | AMD Medicom Inc. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Ca | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2 | Accriva Diagnostics, Inc. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: FEMORAL BLOCK TRAY DYNJRA1739B | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: TONSIL PACK CATH, Medline Kit Number/SKU DYNJ65199A | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: DR FERNANDEZ, Medline kit number/SKU DYNJ68808 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost El | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kit: IV START KIT W/HUBGUARD DYNDV2662 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: HarmonyAIR A-Series Surgical Lighting System | Steris Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE KIT/ASK-01601-MM, THORACENTE | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the foll | Abiomed, Inc. | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4 1/8 IN (10 C | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) CAROTID NEURO PACK, Medline Kit Number/SKU DYNJ4492 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) CRANI, Medline Kit Number/SKU DYNJ908097; 2) CRAN | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, etc. (see th | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. C | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Pre-connected Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Produc | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are | BD SWITZERLAND SARL | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: BASIC DYNJ905869G BASIC PACK DYNJ68484B BIB GENERAL LAPAROSCOPY | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500 | GE Medical Systems, LLC | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Urethral Catheterization Tray, Red Rubber Latex, Medline Product Number/SKU (REF), French si | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1 1/2IN/NA-04220-S | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Urethral Catheterization Tray and Bag, Red Rubber Latex, 15 Fr, Medline Product Number/SKU ( | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: T | Staar Surgical AG | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400. | Howmedica Osteonics Corp. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. D | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: C SECTION CDS985505G C SECTION PACK DYNJ68260D C-SECTION DYNJ9 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: HYSTERECTOMY PACK-LF DYNJ20485L | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10 CM)/ASK-09803-OSU | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 | Thoratec LLC | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if | Datex-Ohmeda Inc | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09 | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) D AND C PACK, Medline Kit Number/SKU DYNJ53973C; | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY KIT: 19G | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) BR L&D PACK, Medline Kit Number/SKU DYNJ47625B; 2 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as BASIC GYN, CW LAP GYN, D&C HYSTEROSCOPY, CW LAP GYN, DEA | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. C | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR X 16 CM/AK-1 | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) KIT UROLOGY URETHROPLASTY, Medline Kit Number/SKU D | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitati | Datex-Ohmeda Inc | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: BREAST-HERNIA-PORT CDS-LF CDS984853L | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Produc | Datex-Ohmeda Inc | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L: 4.5FR X 15C | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: i | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Cat | Inspire Medical Systems Inc. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: C-SECTION KIT DYNJ904305J C-SECTION PACK DYNJ69533C | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Intermittent Latex Catheter Coude Pre-Connected to Collection Bag, 16 Fr, 1000mL, Medline Pr | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline EBSI Kit EBSI1534 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 | Merit Medical Systems, Inc. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W CHG/SAC-01218-C; S | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PICC ACCESS TRAY/ASK-04001-CG1 | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANES | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20 CM/AK-15123-P | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5 IN/ASK-04020-MW; | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: ACCESS TRAY/ASK-04001-MC3 | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as CLOVIS HYSTEROSCOPY, CSC-N PELVISCOPY, D AND C PACK, D&C H | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kit: (82)LABOR & DELIVERY C-SECTION DYNJ907895F | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: BILAT MICRO VASECTOMY REVERSAL, Medline Kit Number/SKU | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kit: HERNIA REPAIR TOTE DYNJ908337D | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kit: SMSC-PELVISCOPY PACK-LF DYNJ0161619M | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: WT LAVH PACK DYNJ46609F | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3 LUMEN 7 FR X | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: PELVIC LAP PACK, Medline Kit Number/ SKU DYNJ53820B | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PAC | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI132 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKC | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04 | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. C | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog | Thoratec LLC | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-1 | ConMed Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PARACENTESIS KIT/ASK-00376-JHH | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US | Thoratec LLC | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: DAVINCI MAIN DYNJ908031D | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRE | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. | Howmedica Osteonics Corp. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. | Abiomed, Inc. | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL CATHETERIZATION KIT: | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+ | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: BREAST IMAGING DYNJT5893 CHOG PLASTICS SYNJ10306A ENDO BREAST A | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERG | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) BASIC HEART PACK, Medline Kit/SKU DYNJ67331B; 2) | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: 1) CHEST EXPLORATION ECMO, Medline Kit Number/SKU DYNJ | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR X 16 CM/ASK- | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: CATH 22F ROBINSON STRL 5'S PK, Medline Kit Number/SKU DY | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Num | Inspire Medical Systems Inc. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medtronic O-arm O2 Imaging System. Model Number: BI70002000. | Medtronic Navigation, Inc.-Boxborough | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MEDLINE Medical Procedure Kits labeled as: LAPAROSCOPY COMBINED - NO NDL, Medline Kit Number/SKU DY | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: PORT A CATH DYNJ906818A | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kit: BHS NEURO DYNJ904900N MEDTRX NEURO PACK DYNJ67267B MRI DBS PACK | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRA | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Mito Red Light, Super Mobile | MITO RED LIGHT INC | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: HarmonyAIR A-Series Surgical Lighting System | Steris Corporation | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297 | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: iLet Bionic Pancreas, REF: BB1001 | Beta Bionics, Inc. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT E | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline convenience kits: INPATIENT CENTRAL LN DRSG KIT DYNDC3525 PICC/CVC/MIDLINE DRSG CHG K | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: MINOR CATH LAB PACK DYNJ84775A OR VASCULAR ANGIO PACK DYNJ47269D PORT-A-CATH DYNJ63276G | Medline Industries, LP | Class II | N/A |
| 2026-06-24 | FDA Device | FDA Recall: Medline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716 | Medline Industries, LP | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100 | Fresh Roast Systems Inc | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 3 | BERLIN HEART GMBH | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Sc | Medartis AG | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28 | Inter-Med Llc | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940 | INSPIREMD Inc | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Plum Duo Infusion Pump, 40002-0401 | ICU Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040 | INSPIREMD Inc | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Halyard, Eye Bag Pack. Kit Code: UIEB48-01. | AVID Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Hintermann Series Talar Implant, Left, Size 2 REF 302112 | DT MedTech, LLC | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water V | Boston Scientific Corporation | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | Philips North America Llc | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Halyard, Drape Pack. Kit Code: LMDP36-01. | AVID Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Num | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr P | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: CORFLO Safety PEG Kit with ENFit Connector Model/Catalog Number: 50-6316 Product Des | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Plum Duo Precision IV Pump, 40002-0403 | ICU Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320 | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316 | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE | HF Acquisition Co LLC | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930 | INSPIREMD Inc | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Boston Scientific TCN Electrodes: REF: TCN-5, TCN Electrode, NITINOL, 5 cm x 0.45 mm (0.0175 in); | Boston Scientific Neuromodulation Corporation | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: MOSAIQ Oncology Information System | Elekta, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE | HF Acquisition Co LLC | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Halyard, Pain Pack. Kit Code: AMPK48-01. | AVID Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Allia IGS Pulse angiographic X-ray system | GE Medical Systems, LLC | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Ve | The Binding Site Group, Ltd. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr P | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr P | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Halyard, Towel Six Pack. Kit Code: AMTS70-01. | AVID Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr P | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-6312 | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6312 | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: NexxZr T Multi A3.5 W98-16mm, REF: 745451 | Sagemax Bioceramics, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Num | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-4 | Fresenius Medical Care Holdings, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 | Boston Scientific Neuromodulation Corporation | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.3 | Boston Scientific Neuromodulation Corporation | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Brand Name: CORFLO Product Name: CORFLO Safety PEG Kit Model/Catalog Number: 30-5320 | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Num | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr P | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-5320 | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320 | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Bicarby Dialysate; Model number: RFP-400-G; | Fresenius Medical Care Holdings, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030 | INSPIREMD Inc | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr P | Avanos Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830 | INSPIREMD Inc | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Allia IGS 3 Pulse angiographic X-ray system | GE Medical Systems, LLC | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Plum Solo Precision IV Pump, 40001-0401 | ICU Medical, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software | Abbott Medical | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Allia IGS 7 Pulse angiographic X-ray system | GE Medical Systems, LLC | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Allia IGS 5 Pulse angiographic X-ray system | GE Medical Systems, LLC | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoass | Siemens Healthcare Diagnostics, Inc. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firm | Micromed S.p.A. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 | In2bones USA, LLC | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Cathete | Mozarc Medical US LLC | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840 | INSPIREMD Inc | Class II | N/A |
| 2026-06-17 | FDA Device | FDA Recall: Allia Moveo angiographic X-ray system | GE Medical Systems, LLC | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 | GE Medical Systems Information Technologies Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Atlan A350. Model Number: 8211500. anesthesia workstation | Draeger, Inc. | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10 | Kico Knee Innovation Company | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042 | Covidien LLC | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044 | Covidien LLC | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD Pyxis MedStation 4000 REF: 303 Medication cabinet | CareFusion 303, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife | SSC- Surgical Specialties Corporation | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire | Shimadzu Medical Systems | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet | CareFusion 303, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. | Fresenius Kabi USA, LLC | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRA | B Braun Medical Inc | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 | Oculus Technologies of Mexico, S.A. de C.V. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD¿Spinal Tray with BD¿Quincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.7 | Becton Dickinson & Company | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0. | Becton Dickinson & Company | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Des | Grace Medical, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Mod | Siemens Medical Solutions USA, Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 an | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog Number: 570246 | B Braun Medical Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD Pyxis MedStation ES REF: 323 Medication cabinet | CareFusion 303, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.7 | Becton Dickinson & Company | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 | Covidien LLC | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Cata | B Braun Medical Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Mode | Advanced Bionics, LLC | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet | CareFusion 303, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0. | Becton Dickinson & Company | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD Pyxis Mini Main REF: 349 Medication cabinet | CareFusion 303, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software | Intuitive Surgical, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Ava | Bayer Medical Care, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: | B Braun Medical Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD¿Spinal Tray with BD¿Quincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.7 | Becton Dickinson & Company | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number | B Braun Medical Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Managem | Stryker Corporation | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Atlan A350XL. Model Number: 8621600. anesthesia workstation | Draeger, Inc. | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050 | Covidien LLC | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan 26 Ga. x | B Braun Medical Inc | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0. | Becton Dickinson & Company | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog Number: 555498 | B Braun Medical Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | Fresenius Kabi USA, LLC | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD¿Spinal Tray with BD¿Whitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0. | Becton Dickinson & Company | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | Siemens Medical Solutions USA, Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071; | Covidien, LP | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL, bupivacaine HCL (0. | Becton Dickinson & Company | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 an | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717 Model/Catalog Nu | B Braun Medical Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but | Daavlin Distributing Company | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Pediatric care bed; Product Designation: KayserBett IDA; | KAYSERBETTEN GMBH & CO. KG | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm) | DeRoyal Industries Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. | GE Medical Systems China Co., Ltd. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10 | Kico Knee Innovation Company | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet | CareFusion 303, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in., BD¿Quincke Needle 22 G x 3.5 in.; lidocaine H | Becton Dickinson & Company | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 P | Baxter Healthcare Corporation | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description (Material | B Braun Medical Inc | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD Pyxis MedStation ES Tower REF: 352 Medication cabinet | CareFusion 303, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Fresenius Kabi USA, LLC | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Numbe | B Braun Medical Inc | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Aligned Medical AMS16835 Fluids Kit RX | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet | CareFusion 303, Inc. | Class II | N/A |
| 2026-06-10 | FDA Device | FDA Recall: BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0. | Becton Dickinson & Company | Class I | N/A |
| 2026-06-10 | FDA Device | FDA Recall: Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalo | B Braun Medical Inc | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) PAIN | Medline Industries, LP | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: GE HealthCare IOU ASSY ARK2250 CARESCAPE TELEMETRY SERVER, REF #2108729-901, Product Code SS9; ApexP | GE Medical Systems Information Technologies Inc | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, im | Medtronic Neuromodulation | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603-902, Produ | GE Medical Systems Information Technologies Inc | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) BLOC | Medline Industries, LP | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPI | Medline Industries, LP | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Cod | Abiomed, Inc. | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction w | GE Medical Systems Information Technologies Inc | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: SPINAL BL | Medline Industries, LP | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINAL | Medline Industries, LP | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) SPINA | Medline Industries, LP | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P | Medline Industries, LP | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANES | Medline Industries, LP | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-1 | Bolton Medical Inc. | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, im | Medtronic Neuromodulation | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 | O&M HALYARD INC | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: GE HealthCare CARESCAPE TELEMETRY SERVER ARK-2250L - NORTH AMERICA, REF #5697603, Product Code KSA; | GE Medical Systems Information Technologies Inc | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), A | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 | Devicor Medical Products Inc | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: Automated Impella Controller (AIC); Product Code: 0042-0000-US; | Abiomed, Inc. | Class I | N/A |
| 2026-06-03 | FDA Device | FDA Recall: GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service | GE Medical Systems Information Technologies Inc | Class II | N/A |
| 2026-06-03 | FDA Device | FDA Recall: GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in c | GE Medical Systems Information Technologies Inc | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T; Cardiopulmo | Medtronic Perfusion Systems | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94115T; Cardiopulmona | Medtronic Perfusion Systems | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valv | ICU Medical, Inc. | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L; Cardiopulmonar | Medtronic Perfusion Systems | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Integris-Allura system; System Code Description (Model Numbers): Integris CV Cesar-Powerpack-Visub-N | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary | Medtronic Perfusion Systems | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TN | TANGENT ENDOSCOPY, LLC | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 3342 | C.R. Bard Inc | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75 | Becton, Dickinson and Company | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P | Becton, Dickinson and Company | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063), Azurion 3 M15 (7220 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94725; Cardiopulmonary | Medtronic Perfusion Systems | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913; Cardiopulmonary | Medtronic Perfusion Systems | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T; Cardiopulmonar | Medtronic Perfusion Systems | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Swan-Ganz Pacing Catheter, Models: D200F7; | Becton, Dickinson and Company | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665; Cardiopulmonary | Medtronic Perfusion Systems | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94915; Cardiopulmonary | Medtronic Perfusion Systems | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Sm | Novapproach Spine, LLC | Class II | N/A |
| 2026-05-27 | FDA Device | FDA Recall: Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below pro | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit SKU Number: | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402; Cardiopulmonary bypass ada | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. MTS,RT,HANDED/LFT,HRT | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6 | GE Medical Systems, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline Kit Number/ | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | Edwards Lifesciences, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App | Dexcom, Inc. | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20 | GE Medical Systems, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software | DJO, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: 3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS | Hologic, Inc | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25 | GE Medical Systems, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 008838739 | Jolife AB | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass ada | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software | DJO, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating | Windstone Medical Packaging, Inc. | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23 | GE Medical Systems, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301; Cardiopulmonary bypass ada | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. T | Integra LifeSciences Corp. (NeuroSciences) | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular blood pressure | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medlin | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15 | GE Medical Systems, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: BARD Dynamic Tip Steerable, Product Number 6DYNTP001; | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 2140 | MICROVENTION INC. | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software | DJO, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS | Hologic, Inc | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028, LABEL, STERI | Omnicell, Inc. | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300 | GE Medical Systems, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular blood pressure | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline Kit Number/S | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on | Medtronic Neuromodulation | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 | On-X Life Technologies, Inc. | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27 | GE Medical Systems, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, A | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube | Stryker Corporation | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp. | Quidel Corporation | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App | Dexcom, Inc. | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS- | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable, Product Number 401905; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Mod | Dexcom, Inc. | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY CATH LAB, | Medline Industries, LP | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, C | ARROW INTERNATIONAL, LLC | Class I | N/A |
| 2026-05-20 | FDA Device | FDA Recall: CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Versi | DJO, LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A | Aniara Diagnostica LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: Diowave Laser System, REF: Diowave 250W | Technological Medical Advancements LLC | Class II | N/A |
| 2026-05-20 | FDA Device | FDA Recall: BW Webster Duo-Decapolar, Product Number D728260RT; REPROCESSED ELECTROPHYSIOLOGY CATHETER | Stryker Sustainability Solutions | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. | BioFire Diagnostics, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY TRAYS, Mod | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Uric Acid in vitro diagnostic test REF: 31H0P | DFI Co., Ltd. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, | Boston Scientific Corporation | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes & CO2 Sources, REF: 20325-239; H | Erbe Medical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-1 | Cook Incorporated | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Halyard CATH LAB kit. Model Number: SACL75-01. | AVID Medical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF40 | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02. | AVID Medical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS9 | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: One Step P in vitro diagnostic test REF: 8194 | DFI Co., Ltd. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02. | AVID Medical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: See RES for complete list. Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SP | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 | Intuitive Surgical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, M | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2) KIT OPHT | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing cathete | Cook Incorporated | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25 | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) PICC CATHETER INSERTION TRAY, Model Number: CVI4300; 2) OSC SHERMAN | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: One Step 10A in vitro diagnostic test | DFI Co., Ltd. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2) DRAPE,SHEET,EC | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029. | AVID Medical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe) | Boston Scientific Corporation | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z | Orthorebirth Co Ltd | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) CENTRAL LINE UNIVERSAL INSERTI, Model Number: CVI3780; 2) LVAD DRIVE | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT W/SYRING | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Nu | Spacelabs Healthcare, Inc. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: QUCARE Total Cholesterol in vitro diagnostic test REF: 6407 | DFI Co., Ltd. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Nu | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GU | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2) KIT SURG | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement. | Centinel Spine, Inc. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Mod | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHES | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: See complete list in RES, exceeds character limit. Medline Surgical Gowns | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25 | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23 | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 | BioFire Diagnostics, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO SHUNT- CODMA | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: One Step pH in vitro diagnostic test REF: 31I4P | DFI Co., Ltd. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343A | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: BioCera Fibers, Bioresorbable Bone Void Filler, REF: ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0 | Orthorebirth Co Ltd | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Nu | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200A | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog | Intuitive Surgical, Inc. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Halyard CATH LAB kit. Model Number: SACL75AM. | AVID Medical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27 | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25 | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, M | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL CUSTOM SP | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: One Step UTI in vitro diagnostic test REF: 3374 | DFI Co., Ltd. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15. | AVID Medical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Mint Lesion; Software Versions: 3.4.0 up to 3.9.5.; | Mint Medical GmbH | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25 | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05. | AVID Medical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01. | AVID Medical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff End Grasping Forceps, Model/Catalog Number: DVF4022-25 | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY: 5/Case | Medical Action Industries, Inc. 306 | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118A | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number:DYKMBNDL55; 2) KIT STC TRACHEOSTO | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) CHEST TUBE INSERTION TRAY, Model Number: DYNDA2941A; 2) CHEST/BREAST | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Mod | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOU | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORT | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating Adaptor COR | American Contract Systems Inc | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tub | Erbe Medical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23 | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222 | Erbe Medical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, | Physio-Control, Inc. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000 | Ventec Life Systems, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2 | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement. | Centinel Spine, Inc. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36. | AVID Medical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: One Step K in vitro diagnostic test REF: 81A4 | DFI Co., Ltd. | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945P | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, M | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN MGMT, Mode | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806L | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05. | AVID Medical, Inc. | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S | Katalyst Surgical, LLC | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in ang | Cook Incorporated | Class I | N/A |
| 2026-05-13 | FDA Device | FDA Recall: See RES for complete list. Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC01 | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS86001 | Medline Industries, LP | Class II | N/A |
| 2026-05-13 | FDA Device | FDA Recall: Medline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT 4 CENTRA | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Mo | Hologic, Inc | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model | Boston Scientific Corporation | Class I | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled a | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled a | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Heraeus, PALAMIX uno. Material Number: 66057893. | Heraeus Medical GmbH (Dental Division) | Class III | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108. | DEPUY (IRELAND) | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPI | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSION | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: i-STAT G3+ cartridge; List Number: 03P78-26; | Abbott Point Of Care Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY P | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105. | DEPUY (IRELAND) | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205. | DEPUY (IRELAND) | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Num | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: iLet Bionic Pancreas, REF: BB1001 | Beta Bionics, Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization | Boston Scientific Corporation | Class I | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. | Siemens Healthcare Diagnostics, Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NE | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutmen | Straumann USA LLC | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208. | DEPUY (IRELAND) | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FR | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEA | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Mod | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Heraeus, PALAMIX duo. Material Number: 66057897. | Heraeus Medical GmbH (Dental Division) | Class III | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous De | Straumann USA LLC | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BA | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Numb | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as speci | North American Rescue LLC. | Class I | N/A |
| 2026-05-06 | FDA Device | FDA Recall: i-STAT EG6+ cartridge; List Number: 03P77-25; | Abbott Point Of Care Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Mode | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODIS | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Ca | Clinical Innovations, LLC | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catal | Zimmer, Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Mode | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PA | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178. | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number ( | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style | Healthmark Industries Co., Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY | Merit Medical Systems, Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of | Immuno-Mycologics, Inc | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107. | DEPUY (IRELAND) | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use | Becton Dickinson & Co. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203. | DEPUY (IRELAND) | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278. | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universa | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOL | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY | Merit Medical Systems, Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. M | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207. | DEPUY (IRELAND) | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOP | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104. | DEPUY (IRELAND) | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Num | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCO | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (102 in total) | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF, | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS | Milestone S.R.L. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO, | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL EN | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor batt | WHILL, INC. | Class I | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCE | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, | WHILL, INC. | Class I | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroes | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use | Becton Dickinson & Co. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Numbe | Advanced Bionics, LLC | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130. | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Mod | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204. | DEPUY (IRELAND) | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Brand Name: Leksell Vantage Arc System REF: 1053958 | Elekta, Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STE | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLE | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: i-STAT EG7+ cartridge; List Number: 03P76-25; | Abbott Point Of Care Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): | Siemens Healthcare Diagnostics Inc | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY | Merit Medical Systems, Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. | Philips North America | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT | Medline Industries, LP | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for t | Medtronic, Inc. | Class II | N/A |
| 2026-05-06 | FDA Device | FDA Recall: Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118 | Philips North America | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18 | Diversatek Healthcare | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDA | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112 | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, Mod | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440 | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Flamingo Funnel Medium, Model Number SQ20012-02 | SurgiSmoke Solutions | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H | LSL Healthcare Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027Y | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717J | LSL Healthcare Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided wi | Magellan Diagnostics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62 | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAP | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Flamingo Funnel Small, Model Number SQ20012-01 | SurgiSmoke Solutions | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3 | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog N | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Oxoid Agglutinating Sera, Salmonella 9-0 R30957301 | Remel Europe Ltd. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK D | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Access Total T4 Calibrator, Catalog No. 33805 | Beckman Coulter, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOP | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)1080 | ARROW INTERNATIONAL, LLC | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRI | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555 | LSL Healthcare Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331 | ARROW INTERNATIONAL, LLC | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog N | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131 | LSL Healthcare Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI c | ARROW INTERNATIONAL, LLC | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 N | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW P | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system. | Integra LifeSciences Corp. (NeuroSciences) | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx) | Foundation Medicine, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)108019021 | ARROW INTERNATIONAL, LLC | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINO | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATH | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08 | Diversatek Healthcare | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554 | LSL Healthcare Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Cat | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-25 | XTANT Medical Holdings, Inc | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and | Uvlizer c/o RAIS INTERNATIONAL LLC | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOn | Foundation Medicine, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK- | ARROW INTERNATIONAL, LLC | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0S | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs | Uvlizer c/o RAIS INTERNATIONAL LLC | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE G | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Flamingo Funnel Large, Model Number SQ20012-03 | SurgiSmoke Solutions | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJ | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X | Magellan Diagnostics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Ca | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No. | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided wi | Magellan Diagnostics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Arrowg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK | ARROW INTERNATIONAL, LLC | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) C | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline Co | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number: | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRA | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)2512 | ARROW INTERNATIONAL, LLC | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.: | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030. | Davol, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog N | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-0 | ARROW INTERNATIONAL, LLC | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71 | Micro-X Ltd. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925H | LSL Healthcare Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15 | Diversatek Healthcare | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 03 | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 | Windstone Medical Packaging, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20 | Diversatek Healthcare | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog | Angiodynamics, Inc. | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDO | Medline Industries, LP | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-29 | FDA Device | FDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PAC | Medline Industries, LP | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136. | Linkbio Corp. | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Philips Spectral CT on Rails. Model Number: 728334. | PHILIPS MEDICAL SYSTEMS | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705. | B Braun Medical Inc | Class I | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. | Integra LifeSciences Corp. (NeuroSciences) | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M20 | B Braun Medical Inc | Class I | N/A |
| 2026-04-22 | FDA Device | FDA Recall: CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F | Medline Industries, LP | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095 | B Braun Medical Inc | Class I | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. | Integra LifeSciences Corp. (NeuroSciences) | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGAN | Clariance-SAS | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software | Beta Bionics, Inc. | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Intervent | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Numbe | THERAKOS DEVELOPMENT LIMITED | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO | Wilson-Cook Medical Inc. | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Yeastone Broth, 11ML, 10/BOX YY3462 | Remel, Inc | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: React Health PHOENIX 5L Oxygen Concentrator | 3B Medical, Inc. | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; | Gentuity, LLC | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA. | B Braun Medical Inc | Class I | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 | Insulet Corporation | Class I | N/A |
| 2026-04-22 | FDA Device | FDA Recall: B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096 | B Braun Medical Inc | Class I | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. | Integra LifeSciences Corp. (NeuroSciences) | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. | Integra LifeSciences Corp. (NeuroSciences) | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: ARTIS Pheno VE30A and VE40A, Model 10849000 | Siemens Medical Solutions USA, Inc | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. | Integra LifeSciences Corp. (NeuroSciences) | Class II | N/A |
| 2026-04-22 | FDA Device | FDA Recall: B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705 | B Braun Medical Inc | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C- | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Ord | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Grow | Brahms GmbH | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G5 | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 700750 | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL. | XTANT Medical Holdings, Inc | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM- | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G565 | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-ST | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UN | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Num | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor | Spacelabs Healthcare, Inc. | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 | Tornier, Inc | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: See Luer Cap Set, MPC-130, set, administration, intravascular | Molded Products Inc | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: MicroScan Neg MIC 3J REF C54814 | Beckman Coulter, Inc. | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242 | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G507 | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, | Siemens Medical Solutions USA, Inc | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A- | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5 | Stryker Sustainability Solutions | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24 | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-P | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medl | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For | Beckman Coulter, Inc. | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; | Medline Industries, LP | Class I | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Spectrum¿ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Orde | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Nu | Cook Incorporated | Class II | N/A |
| 2026-04-15 | FDA Device | FDA Recall: COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Numb | Cook Incorporated | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle D | Intuitive Surgical, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-1 | Mentor Texas, LP. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US. | Synthes (USA) Products LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Allura Xper FD10C; System Code: 722001; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MEDLINE ANTERIOR HIP PACK DYNJ64672B | Medline Industries, LP | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/ | ReCor Medical Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Vue Motion V12. Product Number: 1017979. | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only); | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forc | Intuitive Surgical, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Allura Xper FD20/15; System Code: 722058; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. | Philips Respironics, Inc. | Class I | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Caps. | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915 | Medline Industries, LP | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Blockers. | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001 | Stryker Communications | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Thyroid Shield. | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 | Civco Medical Instruments Co. Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Doubl | Intuitive Surgical, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFL | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BR | Medline Industries, LP | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Allura Xper FD20/20 OR Table; System Code: 722039; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator devic | Philips Respironics, Inc. | Class I | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxte | Baxter Healthcare Corporation | Class I | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilat | Philips Respironics, Inc. | Class I | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator devi | Philips Respironics, Inc. | Class I | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 | Reflexion Medical, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only); | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Frontal Aprons | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MiniMed 530G Insulin Pump (MMT-551, MMT-751) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOP | Medline Industries, LP | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 | Civco Medical Instruments Co. Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC | Medline Industries, LP | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retr | Intuitive Surgical, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height | Mentor Texas, LP. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLE | Medline Industries, LP | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in | Abiomed, Inc. | Class I | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Kilt Blockers. | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFIT | Medline Industries, LP | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 S | Mentor Texas, LP. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536; | Siemens Healthcare Diagnostics, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1 | Abiomed, Inc. | Class I | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem | Oxoid Australia Pty Limited | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Azurion 5 M12; System Code: (1)722227, (2)722231; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 | Civco Medical Instruments Co. Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Paradigm Insulin Pump (MMT-712, MMT-715) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Airway Exam Kit, DYKE1796 | Medline Industries, LP | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 | Civco Medical Instruments Co. Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: BD Kiestra" ReadA; Catalog No.: 446948. | BD KIESTRA LAB AUTOMATION | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MiniMed 620G Insulin Pump (MMT-1750) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 | Civco Medical Instruments Co. Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Allura Xper FD20/15 OR Table; System Code: 722059; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Leg Wraps. | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135 | Mentor Texas, LP. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Kilt | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 | Civco Medical Instruments Co. Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: ALLURA Xper FD10F; System Code: 722002; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser Sy | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Cata | SUMMA THERAPEUTICS, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only); | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Mon | Intuitive Surgical, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/ | ReCor Medical Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011. | Ultradent Products, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Protective Sleeves. | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Vest | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 | Civco Medical Instruments Co. Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: SIGNA Premier systems | GE Healthcare LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Demi Half Aprons. | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Sterile Radiology Procedure Kits, Model Number DYNDH1491B | Medline Industries, LP | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-12 | Mentor Texas, LP. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: THORACIC ROBOTS, DYNJ908777B | Medline Industries, LP | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent | Intuitive Surgical, Inc. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Half Aprons. | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, Wrap Aprons. | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135U | Mentor Texas, LP. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 | Cardinal Health 200, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC | Mentor Texas, LP. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage. | Burlington Medical, LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Allura Xper FD20/10; System Code: 722029; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US. | Synthes (USA) Products LLC | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: Allura Xper FD20/20; System Code: 722038; | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Class II | N/A |
| 2026-04-08 | FDA Device | FDA Recall: eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 | Civco Medical Instruments Co. Inc. | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips L17-5 Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co | Navajo Manufacturing Company | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Mod | Koven Technology, Inc. | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620; | Straumann USA LLC | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding art | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance | AMO Puerto Rico Manufacturing, Inc. | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips X7-2 Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. A | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips X3-1 Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog Nu | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator devic | Philips Respironics, Inc. | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilat | Philips Respironics, Inc. | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System | Orthalign, Inc | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System | Orthalign, Inc | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/C | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device. | Philips Respironics, Inc. | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-N | Merit Medical Systems, Inc. | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below description | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. | Erbe USA Inc | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips S5-2 Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips OMNI II TEE Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for us | Beckman Coulter, Inc. | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical use | Erbe USA Inc | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article num | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutti | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips OMNI III TEE Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article n | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, | Merit Medical Systems, Inc. | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator devi | Philips Respironics, Inc. | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | CareFusion 303, Inc. | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 | Medtronic MiniMed, Inc. | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B | Merit Medical Systems, Inc. | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin | Tandem Diabetes Care, Inc. | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H | Merit Medical Systems, Inc. | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article n | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions a | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" | Medline Industries, LP | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips L12-5 Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps Mode | Olympus Corporation of the Americas | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical use | Erbe USA Inc | Class I | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Hume | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31 | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Artic | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips 3D6-2 Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descr | I.T.S. GmbH | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438; | Straumann USA LLC | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips S4-1 Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips Mini Multi TEE Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Philips C9-4 Ultrasound Transducer | Philips Ultrasound, Inc | Class III | N/A |
| 2026-04-01 | FDA Device | FDA Recall: Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Num | GE Medical Systems, LLC | Class II | N/A |
| 2026-04-01 | FDA Device | FDA Recall: DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H7871 | Merit Medical Systems, Inc. | Class I | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm | ConvaTec, Inc | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Cub Pediatric Crib, Model FL19H | Stryker Medical Division of Stryker Corporation | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Produ | Diagnostica Stago, Inc. | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma | Elekta, Inc. | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm | ConvaTec, Inc | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Battery Charging Station; Model: 0998-00-0802; | Datascope Corp. | Class III | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays m | GE Medical Systems, LLC | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applic | Abbott Diagnostics Scarborough, Inc. | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medica | GE Medical Systems, LLC | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog N | Baxter Healthcare Corporation | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm | ConvaTec, Inc | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product | Hologic, Inc. | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: MICS3 Angled Sagittal Saw Attachment; Part Number: 210490 | Howmedica Osteonics Corp. | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Artegraft Vascular Graft; REF#: AG740; | LeMaitre Vascular, Inc. | Class II | N/A |
| 2026-03-25 | FDA Device | FDA Recall: Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medic | GE Medical Systems, LLC | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Part No. 00055445010 & 00055445011. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat | Altruan GmbH | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UP | Boston Scientific Corporation | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000 PAK; Part No. 00055407504. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-0027/16; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-8521/11; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 | Physio-Control, Inc. | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Part No. 00055445008. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 | Penner Patient Care, Inc. | Class III | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-0027/12; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1 | Penner Patient Care, Inc. | Class III | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Part No. 00055445004. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 36 | Penner Patient Care, Inc. | Class III | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Part No. 00055415010. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-0027/15; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Q | International Life Sciences | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010 | KOB GmbH | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370 | Penner Patient Care, Inc. | Class III | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Artelon FlexBand Plus Ref: 41054 & 41057 | International Life Sciences | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring d | Trividia Health, Inc. | Class I | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000 PAK; Part No. 00055360008. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBAS | Covidien LLC | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Penner Pacific Bathing Spa, Model Numbers 860010-1L | Penner Patient Care, Inc. | Class III | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000 PAK; Part No. 00055407510. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000 PAK; Part No. 00055407508. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Part No: 00055415011. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000 PAK; Part No. 00055360010. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: CLARITY II Laser System; Model No. 1110200210. | Lutronic Corporation | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL | Penner Patient Care, Inc. | Class III | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-8521/15; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-8030/12; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Part No. 00055415005. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Artelon FlexBand Dynamic Matrix Ref: 31057 | International Life Sciences | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement | Trividia Health, Inc. | Class I | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Part No. 00055430008. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-8521/09; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 | Beckman Coulter Mishima K.K. | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000 PAK, Part No. 00055360004. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Penner Pacific Bathing Spa, Model Numbers 360020-1P | Penner Patient Care, Inc. | Class III | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-2836/11; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Part No. 00055430004. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16 | Medartis AG | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-D | Medline Industries, LP | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000 PAK; Part No. 00055415004. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL | Medline Industries, LP | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Part No. 00055430011. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X | Penner Patient Care, Inc. | Class III | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X | Exactech, Inc. | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring d | Trividia Health, Inc. | Class I | N/A |
| 2026-03-18 | FDA Device | FDA Recall: IBA Proton Therapy System - PROTEUS 235 | Ion Beam Applications S.A. | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units pe | Becton Dickinson & Company | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in | Altruan GmbH | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16 | Medartis AG | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: DxC 700 AU, REF: B86444, B86446 | Beckman Coulter Mishima K.K. | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000 PAK; Part No. 00055360011. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, | Penner Patient Care, Inc. | Class III | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-2835/12; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Penner Pacific Bathing Spa, Model Numbers 360020-1EP | Penner Patient Care, Inc. | Class III | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09- | Exactech, Inc. | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Numbe | Medline Industries, LP | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000 PAK; Part No. 00055407511. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Part No. 00055415008. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infe | Altruan GmbH | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: GEM Premier 5000; Model No. 00055430010. | Instrumentation Laboratory | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)006287580 | Raz Design Inc | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring d | Trividia Health, Inc. | Class I | N/A |
| 2026-03-18 | FDA Device | FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-0027/11; | Waldemar Link GmbH & Co. KG (Mfg Site) | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 h | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: F | Aesculap Inc | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: CS100 IABP. Software Version CS100 IABP Q.01. | Datascope Corp. | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lit | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Atellica CH Urine Albumin (UAlb). Material Number: 11537225 | Siemens Healthcare Diagnostics, Inc. | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5 | Staar Surgical AG | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B30 | B Braun Medical Inc | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, m | Roche Diagnostics Operations, Inc. | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038 | ESAOTE S.P.A. | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Numb | Diagnostica Stago, Inc. | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Gener | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Impella RP with SmartAssist. Product Code: 0046-0035. | Abiomed, Inc. | Class I | N/A |
| 2026-03-11 | FDA Device | FDA Recall: GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 211034 | GE Healthcare | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Impella RP Flex with SmartAssist. Product Code: 1000323. | Abiomed, Inc. | Class I | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Vers | B Braun Medical Inc | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 6 | Vascutek, Ltd. | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: CS300 IABP. Software Version CS300 IABP C.01. | Datascope Corp. | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 S | B Braun Medical Inc | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog | Advanced Bionics, LLC | Class II | N/A |
| 2026-03-11 | FDA Device | FDA Recall: Impella RP. Product Code: 0046-0011. | Abiomed, Inc. | Class I | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Ai | Agiliti Health - Ellis | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological appl | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, S | Encore Medical, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological appli | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A | Medline Industries, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, M | Medline Industries, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applicat | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applicat | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for ur | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 | Medtronic Perfusion Systems | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528 | Medline Industries, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALY | Medline Industries, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Me | Medline Industries, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36M | Encore Medical, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used | MRIMed Inc. | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological appl | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for uro | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chlo | Medline Industries, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: PIE PAK Models: P2HC-A, P2HC-S, P2HC | Edermy LLC | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341 | Encore Medical, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological ap | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in u | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746 | Medline Industries, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Campy CVA Medium 100/PK, R01272 | Remel, Inc | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167 | Medline Industries, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications. | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A; | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210 | Medline Industries, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological appli | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applica | Olympus Corporation of the Americas | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 M | Medline Industries, LP | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: PIE Trolley System Model: 2005 | Edermy LLC | Class II | N/A |
| 2026-03-04 | FDA Device | FDA Recall: Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214 | Medline Industries, LP | Class II | N/A |