Medical Device Recalls

598
Recalls
0
Units Recalled
0
Injuries
0
Deaths

122 brands ยท 2026-03-04 to 2026-05-06

DateSourceProductBrandSeverityUnits
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.DEPUY (IRELAND)Class IIN/A
2026-05-06FDA DeviceFDA Recall: Heraeus, PALAMIX uno. Material Number: 66057893.Heraeus Medical GmbH (Dental Division)Class IIIN/A
2026-05-06FDA DeviceFDA Recall: Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled aMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled aMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. BLOOD Medline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Boston Scientific CorporationClass IN/A
2026-05-06FDA DeviceFDA Recall: Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) MoHologic, IncClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC Medline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for tMedtronic, Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT Medline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEADMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLYMerit Medical Systems, Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN):Siemens Healthcare Diagnostics IncClass IIN/A
2026-05-06FDA DeviceFDA Recall: i-STAT EG7+ cartridge; List Number: 03P76-25;Abbott Point Of Care Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Brand Name: Leksell Vantage Arc System REF: 1053958Elekta, Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.DEPUY (IRELAND)Class IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. ModPhilips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LFMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog NumbeAdvanced Bionics, LLCClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR Medline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1Medline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260.Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, NeuroesMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. MPhilips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: EH BRONCHOSCOPMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.DEPUY (IRELAND)Class IIN/A
2026-05-06FDA DeviceFDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.DEPUY (IRELAND)Class IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model NumPhilips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNTMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic useBecton Dickinson & Co.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battWHILL, INC.Class IN/A
2026-05-06FDA DeviceFDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.DEPUY (IRELAND)Class IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCEMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,Medline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SSMilestone S.R.L.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.DEPUY (IRELAND)Class IIN/A
2026-05-06FDA DeviceFDA Recall: Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing ofImmuno-Mycologics, IncClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYMerit Medical Systems, Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLYMerit Medical Systems, Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end styleHealthmark Industries Co., Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF,Medline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO PAMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. ModePhilips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/CatalZimmer, Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic useBecton Dickinson & Co.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICSMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/CaClinical Innovations, LLCClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (102 in total)Medline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANIMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. ModePhilips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, WHILL, INC.Class IN/A
2026-05-06FDA DeviceFDA Recall: i-STAT EG6+ cartridge; List Number: 03P77-25;Abbott Point Of Care Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as speciNorth American Rescue LLC.Class IN/A
2026-05-06FDA DeviceFDA Recall: Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model NumbPhilips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. NEURO BAMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous DeStraumann USA LLCClass IIN/A
2026-05-06FDA DeviceFDA Recall: Heraeus, PALAMIX duo. Material Number: 66057897.Heraeus Medical GmbH (Dental Division)Class IIIN/A
2026-05-06FDA DeviceFDA Recall: Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. ModPhilips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS Medline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEAMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2.Philips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FRMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.DEPUY (IRELAND)Class IIN/A
2026-05-06FDA DeviceFDA Recall: Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant AbutmenStraumann USA LLCClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled asMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MAJOR NEMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KITMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.Siemens Healthcare Diagnostics, Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-SynchronizationBoston Scientific CorporationClass IN/A
2026-05-06FDA DeviceFDA Recall: iLet Bionic Pancreas, REF: BB1001Beta Bionics, Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model NumPhilips North AmericaClass IIN/A
2026-05-06FDA DeviceFDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.DEPUY (IRELAND)Class IIN/A
2026-05-06FDA DeviceFDA Recall: Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.DEPUY (IRELAND)Class IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: UniversaMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: i-STAT G3+ cartridge; List Number: 03P78-26;Abbott Point Of Care Inc.Class IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACKMedline Industries, LPClass IIN/A
2026-05-06FDA DeviceFDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINAL FUSIONMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided wiMagellan Diagnostics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2) SYRINGE 10ML Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035Angiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and Uvlizer c/o RAIS INTERNATIONAL LLCClass IIN/A
2026-04-29FDA DeviceFDA Recall: Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71Micro-X Ltd.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2119.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: Angiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTHROSCOPMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Access Total T4 Calibrator, Catalog No. 33805Beckman Coulter, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C; 3) LH 3Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Flamingo Funnel Small, Model Number SQ20012-01SurgiSmoke SolutionsClass IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes JUDKINS Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 100CM 038 NB 0SH; Catalog No.:Angiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes Medline CoMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model Number: DYNJMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: LSL Healthcare Wound Closure Tray, Model/Catalog Number: 7554LSL Healthcare Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F XAngiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI cARROW INTERNATIONAL, LLCClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog NAngiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET REF ASK-0ARROW INTERNATIONAL, LLCClass IIN/A
2026-04-29FDA DeviceFDA Recall: LSL Healthcare, Infant Central Line Dressing Change Kit, Model/Catalog Number: 2925HLSL Healthcare Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog Number: 1050030.Davol, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs Uvlizer c/o RAIS INTERNATIONAL LLCClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SAngiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER REF ASK-ARROW INTERNATIONAL, LLCClass IIN/A
2026-04-29FDA DeviceFDA Recall: Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOnFoundation Medicine, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCIMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-25XTANT Medical Holdings, IncClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; CatAngiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254BMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Diversatek Healthcare Viperยฟ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08Diversatek HealthcareClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog Angiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADULT CATHMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes FACE/RHINOMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: PERCUTANEOUS SHEATH INTRODUCER with 7.5 - 8 Fr. Catheter REF ASK-09903-MGH3 UDI code: (01)108019021ARROW INTERNATIONAL, LLCClass IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.Integra LifeSciences Corp. (NeuroSciences)Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD KIT LOW PMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NAngiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131LSL Healthcare Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog NAngiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Diversatek Healthcare Viperยฟ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20Diversatek HealthcareClass IIN/A
2026-04-29FDA DeviceFDA Recall: Pressure Injectable Arrowg+ard Blue Plusยฟ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)1080ARROW INTERNATIONAL, LLCClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog NoAngiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: ARROW RADIAL ARTERY CATHETERIZATION KIT REF ASK-04220-UCL1 UDI code: (01)10801902159127(17)270331ARROW INTERNATIONAL, LLCClass IIN/A
2026-04-29FDA DeviceFDA Recall: Diversatek Healthcare Viperยฟ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15Diversatek HealthcareClass IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be includedOlympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes TAVR PACK Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555LSL Healthcare Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543AMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BARIATRIMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK, Model Number:Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog Angiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML CONTROL MLL, Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.:Angiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog NAngiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Oxoid Agglutinating Sera, Salmonella 9-0 R30957301Remel Europe Ltd.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517DMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)Foundation Medicine, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ARTERIOGRAMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 03Angiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433Windstone Medical Packaging, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog Angiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648AMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD A ENDOMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes MINOR ENT Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Diversatek Healthcare Viperยฟ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18Diversatek HealthcareClass IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257FMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model Number: DYNDAMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2112Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY PACK-LF, ModMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Flamingo Funnel Medium, Model Number SQ20012-02SurgiSmoke SolutionsClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE Medline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717HLSL Healthcare Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027YMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: LSL Healthcare, Standard Central Line Dressing Change Kit, Model/Catalog Number: 2717JLSL Healthcare Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994AWindstone Medical Packaging, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138.Olympus Corporation of the AmericasClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813DMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)2512ARROW INTERNATIONAL, LLCClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777DMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number: DYNDH2104; 3) CMedline Industries, LPClass IIN/A
2026-04-29FDA DeviceFDA Recall: Arrowg+ard Blueยฟ MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASKARROW INTERNATIONAL, LLCClass IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; CatalogAngiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: Angiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: LeadCareยฟ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCareยฟ Plus kit is provided wiMagellan Diagnostics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.Angiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; CaAngiodynamics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994Windstone Medical Packaging, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: (1)(2) LeadCareยฟ II Blood Lead Test Kit, (3)LeadCareยฟ II 5X Blood Lead Test Kit, (4)LeadCareยฟ II 9X Magellan Diagnostics, Inc.Class IIN/A
2026-04-29FDA DeviceFDA Recall: Flamingo Funnel Large, Model Number SQ20012-03SurgiSmoke SolutionsClass IIN/A
2026-04-22FDA DeviceFDA Recall: Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.Integra LifeSciences Corp. (NeuroSciences)Class IIN/A
2026-04-22FDA DeviceFDA Recall: Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.Integra LifeSciences Corp. (NeuroSciences)Class IIN/A
2026-04-22FDA DeviceFDA Recall: B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096B Braun Medical IncClass IN/A
2026-04-22FDA DeviceFDA Recall: B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.B Braun Medical IncClass IN/A
2026-04-22FDA DeviceFDA Recall: B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M20B Braun Medical IncClass IN/A
2026-04-22FDA DeviceFDA Recall: Cytal Burn Matrix 10x15 cm. Product ID: BMM1015.Integra LifeSciences Corp. (NeuroSciences)Class IIN/A
2026-04-22FDA DeviceFDA Recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7Insulet CorporationClass IN/A
2026-04-22FDA DeviceFDA Recall: React Health PHOENIX 5L Oxygen Concentrator3B Medical, Inc.Class IIN/A
2026-04-22FDA DeviceFDA Recall: LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.Linkbio Corp.Class IIN/A
2026-04-22FDA DeviceFDA Recall: Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.Integra LifeSciences Corp. (NeuroSciences)Class IIN/A
2026-04-22FDA DeviceFDA Recall: B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705B Braun Medical IncClass IN/A
2026-04-22FDA DeviceFDA Recall: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 USARJOHUNTLEIGH POLSKA Sp. z.o.o.Class IIN/A
2026-04-22FDA DeviceFDA Recall: Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;Gentuity, LLCClass IIN/A
2026-04-22FDA DeviceFDA Recall: Yeastone Broth, 11ML, 10/BOX YY3462Remel, IncClass IIN/A
2026-04-22FDA DeviceFDA Recall: Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EOWilson-Cook Medical Inc.Class IIN/A
2026-04-22FDA DeviceFDA Recall: Brand Name: Eleganceยฟ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANClariance-SASClass IIN/A
2026-04-22FDA DeviceFDA Recall: Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog NumbeTHERAKOS DEVELOPMENT LIMITEDClass IIN/A
2026-04-22FDA DeviceFDA Recall: Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (InterventPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-22FDA DeviceFDA Recall: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision SoftwareBeta Bionics, Inc.Class IIN/A
2026-04-22FDA DeviceFDA Recall: Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.Integra LifeSciences Corp. (NeuroSciences)Class IIN/A
2026-04-22FDA DeviceFDA Recall: ARTIS Pheno VE30A and VE40A, Model 10849000Siemens Medical Solutions USA, IncClass IIN/A
2026-04-22FDA DeviceFDA Recall: Philips Spectral CT on Rails. Model Number: 728334.PHILIPS MEDICAL SYSTEMSClass IIN/A
2026-04-22FDA DeviceFDA Recall: B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095B Braun Medical IncClass IN/A
2026-04-22FDA DeviceFDA Recall: B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.B Braun Medical IncClass IN/A
2026-04-22FDA DeviceFDA Recall: CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050FMedline Industries, LPClass IIN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G5Cook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, OrdCook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-Cook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 Tornier, IncClass IIN/A
2026-04-15FDA DeviceFDA Recall: See Luer Cap Set, MPC-130, set, administration, intravascularMolded Products IncClass IIN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: MicroScan Neg MIC 3J REF C54814Beckman Coulter, Inc.Class IIN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242Cook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027;Medline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G507Cook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, Siemens Medical Solutions USA, IncClass IIN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Spectrumยฟ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-Cook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5Stryker Sustainability SolutionsClass IIN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24Cook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PCook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, MedlMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Spectrumยฟ Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, OrdeCook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental GrowBrahms GmbHClass IIN/A
2026-04-15FDA DeviceFDA Recall: NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 700750Medline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: XTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.XTANT Medical Holdings, IncClass IIN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Blue Rhinoยฟ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number Cook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Cookยฟ Spectrumยฟ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-Cook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G565Cook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Cookยฟ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STCook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNCook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number Cook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL NCompassยฟ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order NumCook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027;Medline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order NuCook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: Multi-parameter Command Module, Model 91496, optioned with Masimo or NellcorSpacelabs Healthcare, Inc.Class IIN/A
2026-04-15FDA DeviceFDA Recall: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control SyringMedline Industries, LPClass IN/A
2026-04-15FDA DeviceFDA Recall: COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order NumbCook IncorporatedClass IIN/A
2026-04-15FDA DeviceFDA Recall: MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- ForBeckman Coulter, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Mentor Texas, LP.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping RetrIntuitive Surgical, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GCMedline Industries, LPClass IIN/A
2026-04-08FDA DeviceFDA Recall: ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156Civco Medical Instruments Co. Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPMedline Industries, LPClass IIN/A
2026-04-08FDA DeviceFDA Recall: MiniMed 530G Insulin Pump (MMT-551, MMT-751)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, Frontal ApronsBurlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00Reflexion Medical, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator deviPhilips Respironics, Inc.Class IN/A
2026-04-08FDA DeviceFDA Recall: Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilatPhilips Respironics, Inc.Class IN/A
2026-04-08FDA DeviceFDA Recall: Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to BaxteBaxter Healthcare CorporationClass IN/A
2026-04-08FDA DeviceFDA Recall: Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator devicPhilips Respironics, Inc.Class IN/A
2026-04-08FDA DeviceFDA Recall: Allura Xper FD20/20 OR Table; System Code: 722039;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Medline convenience kits containing Olympus biopsy valves: 1. BRONCH PACK, DYKE2096 2. NON MB BRMedline Industries, LPClass IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Laser System TFLOlympus Corporation of the AmericasClass IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si DoublIntuitive Surgical, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149Civco Medical Instruments Co. Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, Thyroid Shield.Burlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001Stryker CommunicationsClass IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, Blockers.Burlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Medline kits containing Olympus biopsy valves: 1. BAL KIT, DYNDA2137B 2. ENDO KIT, DYKE1915Medline Industries, LPClass IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, Caps.Burlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser SyOlympus Corporation of the AmericasClass IIN/A
2026-04-08FDA DeviceFDA Recall: MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.Burlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Allura Xper FD20/10; System Code: 722029;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.Synthes (USA) Products LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si MonIntuitive Surgical, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: Paradiseยฟ Ultrasound Renal Denervation System Product Name: Paradise ยฟ Catheter Model/ReCor Medical Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Allura Xper FD20/20; System Code: 722038;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-1Mentor Texas, LP.Class IIN/A
2026-04-08FDA DeviceFDA Recall: ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Azurion 7 B12; System Code: (1)722067, (2)722225, (3)722235;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle DIntuitive Surgical, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: 2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.Synthes (USA) Products LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Allura Xper FD10C; System Code: 722001;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: MEDLINE ANTERIOR HIP PACK DYNJ64672BMedline Industries, LPClass IIN/A
2026-04-08FDA DeviceFDA Recall: MiniMed 700G Insulin Pump (MMT-1801, MMT-1805, MMT-1850, MMT-1851)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: Paradiseยฟ Ultrasound Renal Denervation System Product Name: Paradise ยฟ Catheter Model/ReCor Medical Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Vue Motion V12. Product Number: 1017979.PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum ForcIntuitive Surgical, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: ALLURA Xper FD10F; System Code: 722002;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Allura Xper FD20/15 OR Table; System Code: 722059;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Allura Xper FD20/15; System Code: 722058;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.Philips Respironics, Inc.Class IN/A
2026-04-08FDA DeviceFDA Recall: eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152Civco Medical Instruments Co. Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, KiltBurlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135Mentor Texas, LP.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, Leg Wraps.Burlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/CataSUMMA THERAPEUTICS, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159Civco Medical Instruments Co. Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.Ultradent Products, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, Protective Sleeves.Burlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, VestBurlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150Civco Medical Instruments Co. Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: SIGNA Premier systemsGE Healthcare LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, Demi Half Aprons.Burlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Sterile Radiology Procedure Kits, Model Number DYNDH1491BMedline Industries, LPClass IIN/A
2026-04-08FDA DeviceFDA Recall: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-12Mentor Texas, LP.Class IIN/A
2026-04-08FDA DeviceFDA Recall: THORACIC ROBOTS, DYNJ908777BMedline Industries, LPClass IIN/A
2026-04-08FDA DeviceFDA Recall: ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si PermanentIntuitive Surgical, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, Half Aprons.Burlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, Wrap Aprons.Burlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UMentor Texas, LP.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777Cardinal Health 200, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDCMentor Texas, LP.Class IIN/A
2026-04-08FDA DeviceFDA Recall: eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158Civco Medical Instruments Co. Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: MiniMed 620G Insulin Pump (MMT-1750)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: BD Kiestra" ReadA; Catalog No.: 446948.BD KIESTRA LAB AUTOMATIONClass IIN/A
2026-04-08FDA DeviceFDA Recall: Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151Civco Medical Instruments Co. Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Airway Exam Kit, DYKE1796Medline Industries, LPClass IIN/A
2026-04-08FDA DeviceFDA Recall: Paradigm Insulin Pump (MMT-712, MMT-715)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157Civco Medical Instruments Co. Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Azurion 5 M12; System Code: (1)722227, (2)722231;PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIN/A
2026-04-08FDA DeviceFDA Recall: OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystemOxoid Australia Pty LimitedClass IIN/A
2026-04-08FDA DeviceFDA Recall: MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1Abiomed, Inc.Class IN/A
2026-04-08FDA DeviceFDA Recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;Siemens Healthcare Diagnostics, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SMentor Texas, LP.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)Medtronic MiniMed, Inc.Class IIN/A
2026-04-08FDA DeviceFDA Recall: Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITMedline Industries, LPClass IIN/A
2026-04-08FDA DeviceFDA Recall: Burlington Medical, Kilt Blockers.Burlington Medical, LLCClass IIN/A
2026-04-08FDA DeviceFDA Recall: Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in Abiomed, Inc.Class IN/A
2026-04-08FDA DeviceFDA Recall: Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEMedline Industries, LPClass IIN/A
2026-04-01FDA DeviceFDA Recall: Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;Straumann USA LLCClass IIN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS EyhanceAMO Puerto Rico Manufacturing, Inc.Class IIN/A
2026-04-01FDA DeviceFDA Recall: Philips X7-2 Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest BipolarOlympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descrI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. CancellousI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Olympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: Philips OMNI III TEE Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-04-01FDA DeviceFDA Recall: HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. I.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article nI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, Merit Medical Systems, Inc.Class IN/A
2026-04-01FDA DeviceFDA Recall: Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical useErbe USA IncClass IN/A
2026-04-01FDA DeviceFDA Recall: I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article nI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) with the below descriptions aI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.Olympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. I.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar CuttiOlympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H7871Merit Medical Systems, Inc.Class IN/A
2026-04-01FDA DeviceFDA Recall: Philips C9-4 Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-04-01FDA DeviceFDA Recall: Philips Mini Multi TEE Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-04-01FDA DeviceFDA Recall: Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;Straumann USA LLCClass IIN/A
2026-04-01FDA DeviceFDA Recall: Philips 3D6-2 Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-04-01FDA DeviceFDA Recall: HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31I.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Forceps Model/Catalog NuOlympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: Philips X3-1 Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-04-01FDA DeviceFDA Recall: Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-04-01FDA DeviceFDA Recall: Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. I.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. AI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Olympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model NumGE Medical Systems, LLCClass IIN/A
2026-04-01FDA DeviceFDA Recall: Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator deviPhilips Respironics, Inc.Class IN/A
2026-04-01FDA DeviceFDA Recall: Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.Olympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: BD Alaris" System with Guardrails" Suite MX with Point of Care UnitCareFusion 303, Inc.Class IIN/A
2026-04-01FDA DeviceFDA Recall: MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61Medtronic MiniMed, Inc.Class IIN/A
2026-04-01FDA DeviceFDA Recall: Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-04-01FDA DeviceFDA Recall: 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/BMerit Medical Systems, Inc.Class IN/A
2026-04-01FDA DeviceFDA Recall: Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulinTandem Diabetes Care, Inc.Class IIN/A
2026-04-01FDA DeviceFDA Recall: Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.Olympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: Philips L17-5 Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-04-01FDA DeviceFDA Recall: BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, HMerit Medical Systems, Inc.Class IN/A
2026-04-01FDA DeviceFDA Recall: Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products CoNavajo Manufacturing CompanyClass IN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe ModKoven Technology, Inc.Class IIN/A
2026-04-01FDA DeviceFDA Recall: Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.Olympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding artI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal HumeI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical useErbe USA IncClass IN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting Forceps ModeOlympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: Philips L12-5 Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-04-01FDA DeviceFDA Recall: Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. I.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2"Medline Industries, LPClass IIN/A
2026-04-01FDA DeviceFDA Recall: I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for usBeckman Coulter, Inc.Class IIN/A
2026-04-01FDA DeviceFDA Recall: Philips OMNI II TEE Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-04-01FDA DeviceFDA Recall: Philips S5-2 Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-04-01FDA DeviceFDA Recall: Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers.I.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILEEO. Erbe USA IncClass IN/A
2026-04-01FDA DeviceFDA Recall: FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptionI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NMerit Medical Systems, Inc.Class IN/A
2026-04-01FDA DeviceFDA Recall: Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.Philips Respironics, Inc.Class IN/A
2026-04-01FDA DeviceFDA Recall: Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting Forceps Model/COlympus Corporation of the AmericasClass IIN/A
2026-04-01FDA DeviceFDA Recall: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee SystemOrthalign, IncClass IIN/A
2026-04-01FDA DeviceFDA Recall: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee SystemOrthalign, IncClass IIN/A
2026-04-01FDA DeviceFDA Recall: Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilatPhilips Respironics, Inc.Class IN/A
2026-04-01FDA DeviceFDA Recall: Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator devicPhilips Respironics, Inc.Class IN/A
2026-04-01FDA DeviceFDA Recall: FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. ArticI.T.S. GmbHClass IIN/A
2026-04-01FDA DeviceFDA Recall: Philips S4-1 Ultrasound TransducerPhilips Ultrasound, IncClass IIIN/A
2026-03-25FDA DeviceFDA Recall: Convatec, EsteemBody Drainable Pouch REF:423657 10-35mmConvaTec, IncClass IIN/A
2026-03-25FDA DeviceFDA Recall: Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 ProduDiagnostica Stago, Inc.Class IIN/A
2026-03-25FDA DeviceFDA Recall: Battery Charging Station; Model: 0998-00-0802;Datascope Corp.Class IIIN/A
2026-03-25FDA DeviceFDA Recall: Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays mGE Medical Systems, LLCClass IIN/A
2026-03-25FDA DeviceFDA Recall: Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not ApplicAbbott Diagnostics Scarborough, Inc.Class IIN/A
2026-03-25FDA DeviceFDA Recall: Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medicaGE Medical Systems, LLCClass IIN/A
2026-03-25FDA DeviceFDA Recall: Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog NBaxter Healthcare CorporationClass IIN/A
2026-03-25FDA DeviceFDA Recall: Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Hologic, Inc.Class IIN/A
2026-03-25FDA DeviceFDA Recall: MICS3 Angled Sagittal Saw Attachment; Part Number: 210490Howmedica Osteonics Corp.Class IIN/A
2026-03-25FDA DeviceFDA Recall: Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knifeยฟ Perfexion Leksell Gamma Elekta, Inc.Class IIN/A
2026-03-25FDA DeviceFDA Recall: Cub Pediatric Crib, Model FL19HStryker Medical Division of Stryker CorporationClass IIN/A
2026-03-25FDA DeviceFDA Recall: Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mmConvaTec, IncClass IIN/A
2026-03-25FDA DeviceFDA Recall: Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medicGE Medical Systems, LLCClass IIN/A
2026-03-25FDA DeviceFDA Recall: Convatec, EsteemBody Drainable Pouch REF:423653 10-35mmConvaTec, IncClass IIN/A
2026-03-25FDA DeviceFDA Recall: Artegraft Vascular Graft; REF#: AG740;LeMaitre Vascular, Inc.Class IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Part No. 00055415005.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Part No. 00055445010 & 00055445011.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infeAltruan GmbHClass IIN/A
2026-03-18FDA DeviceFDA Recall: Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16Medartis AGClass IIN/A
2026-03-18FDA DeviceFDA Recall: Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat Altruan GmbHClass IIN/A
2026-03-18FDA DeviceFDA Recall: EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPBoston Scientific CorporationClass IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000 PAK; Part No. 00055407504.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model Replacement Plateau; Item Number: 15-0027/16;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model Replacement Plateau; Item Number: 15-8521/11;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 Physio-Control, Inc.Class IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Part No. 00055445008.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2Penner Patient Care, Inc.Class IIIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model Replacement Plateau; Item Number: 15-0027/12;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-1Penner Patient Care, Inc.Class IIIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Part No. 00055445004.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 36Penner Patient Care, Inc.Class IIIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Part No. 00055415010.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model Replacement Plateau; Item Number: 15-0027/15;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (QInternational Life SciencesClass IIN/A
2026-03-18FDA DeviceFDA Recall: MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE, REF NONUNNAS40 KOB article #40307010KOB GmbHClass IIN/A
2026-03-18FDA DeviceFDA Recall: Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370Penner Patient Care, Inc.Class IIIN/A
2026-03-18FDA DeviceFDA Recall: Artelon FlexBand Plus Ref: 41054 & 41057International Life SciencesClass IIN/A
2026-03-18FDA DeviceFDA Recall: Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring dTrividia Health, Inc.Class IN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000 PAK; Part No. 00055360008.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASCovidien LLCClass IIN/A
2026-03-18FDA DeviceFDA Recall: Penner Pacific Bathing Spa, Model Numbers 860010-1LPenner Patient Care, Inc.Class IIIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000 PAK; Part No. 00055407510.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000 PAK; Part No. 00055407508.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Part No: 00055415011.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000 PAK; Part No. 00055360010.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: CLARITY II Laser System; Model No. 1110200210.Lutronic CorporationClass IIN/A
2026-03-18FDA DeviceFDA Recall: Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XLPenner Patient Care, Inc.Class IIIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model Replacement Plateau; Item Number: 15-8521/15;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model Replacement Plateau; Item Number: 15-8030/12;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: Artelon FlexBand Dynamic Matrix Ref: 31057International Life SciencesClass IIN/A
2026-03-18FDA DeviceFDA Recall: Owner's Booklets and Instructions for Use that are used with the following blood glucose measurementTrividia Health, Inc.Class IN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Part No. 00055430008.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model Replacement Plateau; Item Number: 15-8521/09;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281Beckman Coulter Mishima K.K.Class IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000 PAK, Part No. 00055360004.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: Penner Pacific Bathing Spa, Model Numbers 360020-1PPenner Patient Care, Inc.Class IIIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model Replacement Plateau; Item Number: 15-2836/11;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Part No. 00055430004.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16Medartis AGClass IIN/A
2026-03-18FDA DeviceFDA Recall: Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DMedline Industries, LPClass IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000 PAK; Part No. 00055415004.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL Medline Industries, LPClass IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Part No. 00055430011.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-XPenner Patient Care, Inc.Class IIIN/A
2026-03-18FDA DeviceFDA Recall: Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311XExactech, Inc.Class IIN/A
2026-03-18FDA DeviceFDA Recall: Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring dTrividia Health, Inc.Class IN/A
2026-03-18FDA DeviceFDA Recall: IBA Proton Therapy System - PROTEUS 235Ion Beam Applications S.A.Class IIN/A
2026-03-18FDA DeviceFDA Recall: 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units peBecton Dickinson & CompanyClass IIN/A
2026-03-18FDA DeviceFDA Recall: Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in Altruan GmbHClass IIN/A
2026-03-18FDA DeviceFDA Recall: DxC 700 AU, REF: B86444, B86446Beckman Coulter Mishima K.K.Class IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000 PAK; Part No. 00055360011.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC,Penner Patient Care, Inc.Class IIIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model Replacement Plateau; Item Number: 15-2835/12;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: Penner Pacific Bathing Spa, Model Numbers 360020-1EPPenner Patient Care, Inc.Class IIIN/A
2026-03-18FDA DeviceFDA Recall: Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-Exactech, Inc.Class IIN/A
2026-03-18FDA DeviceFDA Recall: Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model NumbeMedline Industries, LPClass IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000 PAK; Part No. 00055407511.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Part No. 00055415008.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: GEM Premier 5000; Model No. 00055430010.Instrumentation LaboratoryClass IIN/A
2026-03-18FDA DeviceFDA Recall: Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)006287580Raz Design IncClass IIN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-18FDA DeviceFDA Recall: Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring dTrividia Health, Inc.Class IN/A
2026-03-18FDA DeviceFDA Recall: Endo-Model Replacement Plateau; Item Number: 15-0027/11;Waldemar Link GmbH & Co. KG (Mfg Site)Class IIN/A
2026-03-11FDA DeviceFDA Recall: Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software VersB Braun Medical IncClass IIN/A
2026-03-11FDA DeviceFDA Recall: Impella RP. Product Code: 0046-0011.Abiomed, Inc.Class IN/A
2026-03-11FDA DeviceFDA Recall: Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Advanced Bionics, LLCClass IIN/A
2026-03-11FDA DeviceFDA Recall: CS300 IABP. Software Version CS300 IABP C.01.Datascope Corp.Class IIN/A
2026-03-11FDA DeviceFDA Recall: Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 6Vascutek, Ltd.Class IIN/A
2026-03-11FDA DeviceFDA Recall: Impella RP with SmartAssist. Product Code: 0046-0035.Abiomed, Inc.Class IN/A
2026-03-11FDA DeviceFDA Recall: Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - GenerOlympus Corporation of the AmericasClass IIN/A
2026-03-11FDA DeviceFDA Recall: Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog NumbDiagnostica Stago, Inc.Class IIN/A
2026-03-11FDA DeviceFDA Recall: Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B30B Braun Medical IncClass IIN/A
2026-03-11FDA DeviceFDA Recall: EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5Staar Surgical AGClass IIN/A
2026-03-11FDA DeviceFDA Recall: Atellica CH Urine Albumin (UAlb). Material Number: 11537225Siemens Healthcare Diagnostics, Inc.Class IIN/A
2026-03-11FDA DeviceFDA Recall: Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE LitOlympus Corporation of the AmericasClass IIN/A
2026-03-11FDA DeviceFDA Recall: CS100 IABP. Software Version CS100 IABP Q.01.Datascope Corp.Class IIN/A
2026-03-11FDA DeviceFDA Recall: Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FAesculap IncClass IIN/A
2026-03-11FDA DeviceFDA Recall: Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 hOlympus Corporation of the AmericasClass IIN/A
2026-03-11FDA DeviceFDA Recall: Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 hasOlympus Corporation of the AmericasClass IIN/A
2026-03-11FDA DeviceFDA Recall: Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 SB Braun Medical IncClass IIN/A
2026-03-11FDA DeviceFDA Recall: Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038ESAOTE S.P.A.Class IIN/A
2026-03-11FDA DeviceFDA Recall: cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, mRoche Diagnostics Operations, Inc.Class IIN/A
2026-03-11FDA DeviceFDA Recall: Impella RP Flex with SmartAssist. Product Code: 1000323.Abiomed, Inc.Class IN/A
2026-03-11FDA DeviceFDA Recall: Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System -Olympus Corporation of the AmericasClass IIN/A
2026-03-11FDA DeviceFDA Recall: GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 211034GE HealthcareClass IIN/A
2026-03-11FDA DeviceFDA Recall: Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System Olympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYMedline Industries, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 MeMedline Industries, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.Olympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MEncore Medical, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.Olympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FRHitachi, Ltd. Radiation Oncology Systems, KashiwanohaClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for uroOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: PIE PAK Models: P2HC-A, P2HC-S, P2HCEdermy LLCClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological apOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Campy CVA Medium 100/PK, R01272Remel, IncClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.Olympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;Olympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological appliOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applicaOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt AiAgiliti Health - EllisClass IIN/A
2026-03-04FDA DeviceFDA Recall: Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA2705 MMedline Industries, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: PIE Trolley System Model: 2005Edermy LLCClass IIN/A
2026-03-04FDA DeviceFDA Recall: Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CRHitachi, Ltd. Radiation Oncology Systems, KashiwanohaClass IIN/A
2026-03-04FDA DeviceFDA Recall: Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214Medline Industries, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.Olympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological Olympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium ChloMedline Industries, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341Encore Medical, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in uOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746Medline Industries, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167Medline Industries, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Meijer STERILE saline wound wash, First Aid Cleansing Spray, 0.9% USP SODIUM CHLORIDE, 7.1FL OZ (210Medline Industries, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, SEncore Medical, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath forOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is usedMRIMed Inc.Class IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological appliOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Medline Industries, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, MMedline Industries, LPClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.Olympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applicatOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath forOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applicatOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urOlympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1Medtronic Perfusion SystemsClass IIN/A
2026-03-04FDA DeviceFDA Recall: Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for Olympus Corporation of the AmericasClass IIN/A
2026-03-04FDA DeviceFDA Recall: Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528Medline Industries, LPClass IIN/A