Medical Device Recalls

933

Recalls

Units Recalled

Injuries

Deaths

Top brands: Medline Industries, LP (183) · Olympus Corporation of the Americas (56) · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. (39) · Stryker Sustainability Solutions (27) · Cook Incorporated (21)

184 brands · 2026-03-04 to 2026-06-17

Date	Source	Product	Brand	Severity	Units
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: 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: Allia IGS 3 Pulse angiographic X-ray system	GE Medical Systems, LLC	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: 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: 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: 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: 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: 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: Allia Moveo angiographic X-ray system	GE Medical Systems, LLC	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: 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: 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: 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 5 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: Allia IGS 7 Pulse angiographic X-ray system	GE Medical Systems, LLC	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: 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: Allia IGS Pulse angiographic X-ray system	GE Medical Systems, 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: 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: 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: 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: 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: MOSAIQ Oncology Information System	Elekta, Inc.	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: DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.	Philips North America Llc	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: 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: 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: Hintermann Series Talar Implant, Left, Size 2 REF 302112	DT MedTech, LLC	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: CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040	INSPIREMD 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: Plum Duo Infusion Pump, 40002-0401	ICU Medical, Inc.	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: CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930	INSPIREMD 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: 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: 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: 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: CORFLO* Safety PEG Kit Model/Catalog Number: 30-6316	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 24 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: 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: 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: 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: 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
2026-06-10	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: 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: 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: 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: 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
2026-06-10	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: 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: 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: 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 Pyxis MedBank Tower REF: 1145-00 Medication cabinet	CareFusion 303, Inc.	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: 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: 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: 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: 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: Atlan A350XL. Model Number: 8621600. anesthesia workstation	Draeger, Inc.	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: 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 RIVERSIDE HEALTH SYSTEM Model/Catalog Number:	B Braun Medical Inc	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: 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: 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: 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: 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 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: 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: 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: BD Pyxis Mini Main REF: 349 Medication cabinet	CareFusion 303, Inc.	Class II	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: 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¿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: 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: 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: BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet	CareFusion 303, 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: 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: 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: 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: BD Pyxis MedStation ES REF: 323 Medication cabinet	CareFusion 303, Inc.	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: 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: 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 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: 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: 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¿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: 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: 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: 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: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.	Fresenius Kabi USA, LLC	Class II	N/A
2026-06-03	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: 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: 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: 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: 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 15FR, Model 94115T; Cardiopulmona	Medtronic Perfusion Systems	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: 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: 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
2026-05-27	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: 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: 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: 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: 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: 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: 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: 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
2026-05-20	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: 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: BARD EP XT Steerable, Product Number 200794; 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 Dynamic XT Deca Steerable, Product Number 201102, 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: Daig Livewire Steerable, Product Number 401908; 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 401923; REPROCESSED ELECTROPHYSIOLOGY CATHETER	Stryker Sustainability Solutions	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: 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: 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 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: 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
2026-05-20	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 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
2026-05-13	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: Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.	AVID Medical, Inc.	Class I	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: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485	BioFire Diagnostics, LLC	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: Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.	AVID Medical, Inc.	Class I	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: 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: 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: 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: 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: 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: 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: Halyard CATH LAB kit. Model Number: SACL75AM.	AVID Medical, Inc.	Class I	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: 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: 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: 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: Uric Acid in vitro diagnostic test REF: 31H0P	DFI Co., Ltd.	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: 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: 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: ERBEFLO 2, Endoscopy Pump Tubing/Cap Set, REF: 20325-222	Erbe Medical, LLC	Class II	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: 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
2026-05-13	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: 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: 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: One Step K in vitro diagnostic test REF: 81A4	DFI Co., Ltd.	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 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: 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: 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: Halyard CATH LAB kit. Model Number: SACL75-01.	AVID Medical, Inc.	Class I	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: 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: 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: 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: 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: 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: 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: 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: 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: One Step P in vitro diagnostic test REF: 8194	DFI Co., Ltd.	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: 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: 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: 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: 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: 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: 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: 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: 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) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031A	Medline Industries, LP	Class II	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: 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: Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.	AVID Medical, Inc.	Class I	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: 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: 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: 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) 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: 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: 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) 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: 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) 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
2026-05-06	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: 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: 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 (4077 in total), LAMINECTOMY, CRANI	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, labeled as follows: 1. SPINE PROCE	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: 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, labeled as follows: 1. PLASTICS	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: 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: 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: 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: 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: 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: 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
2026-05-06	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: SPINAL FUSION	Medline Industries, LP	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: 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: 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, 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: 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 EXTREMITY	Medline Industries, LP	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: 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: 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: 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: 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: Flamingo Funnel Large, Model Number SQ20012-03	SurgiSmoke Solutions	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: 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: 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: 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: 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: 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: 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: 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: 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: 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) 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: Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257F	Medline Industries, LP	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: 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: 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 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 Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PAC	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 ADD A ENDO	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 Kits: 1) PICC TRAY, Model Number: DYNJ41648A	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 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: 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 Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440	Medline Industries, LP	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: 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: 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: Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)	Foundation Medicine, Inc.	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) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517D	Medline Industries, LP	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: 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: 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: 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: 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: 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: 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) 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 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: 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: Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777D	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: 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: 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: 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: 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: 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: 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: 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 EYE PACK D	Medline Industries, LP	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: Flamingo Funnel Small, Model Number SQ20012-01	SurgiSmoke Solutions	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: 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: 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 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: 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: 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: 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) 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: LSL Healthcare, Foley Urine Collection Kit, Model/Catalog Number: 1555	LSL Healthcare Inc.	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: 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: 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: 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: 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: 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: 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: 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: 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
2026-04-22	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: 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: 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: 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, 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 7x10 cm. Product ID: WSM0710.	Integra LifeSciences Corp. (NeuroSciences)	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: Cytal Burn Matrix 7x10 cm. Product ID: BMM0710.	Integra LifeSciences Corp. (NeuroSciences)	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: 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: 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: 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: 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: 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: React Health PHOENIX 5L Oxygen Concentrator	3B Medical, Inc.	Class II	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: B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705	B Braun Medical Inc	Class I	N/A
2026-04-22	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: 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: iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software	Beta Bionics, Inc.	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: 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
2026-04-15	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: 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: 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: 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: 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: 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 Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Numb	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: See Luer Cap Set, MPC-130, set, administration, intravascular	Molded Products Inc	Class II	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: 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: 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 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: 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: 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: 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: 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: 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 MIC 3J REF C54814	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: 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 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: 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: 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: 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: 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: 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-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 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 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 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
2026-04-08	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: eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158	Civco Medical Instruments Co. Inc.	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: 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 FD20/10; System Code: 722029;	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 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: 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: 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-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135U	Mentor Texas, LP.	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: Burlington Medical, Half Aprons.	Burlington Medical, LLC	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: 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: THORACIC ROBOTS, DYNJ908777B	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: Sterile Radiology Procedure Kits, Model Number DYNDH1491B	Medline Industries, LP	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: 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: SIGNA Premier systems	GE Healthcare 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: Burlington Medical, Vest	Burlington Medical, LLC	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: Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.	Ultradent Products, 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: 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: 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: 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: 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: 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: ALLURA Xper FD10F; System Code: 722002;	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	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: 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: Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)	Medtronic MiniMed, Inc.	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: 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: Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)	Medtronic MiniMed, Inc.	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: 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: 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: 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: 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: MiniMed 620G Insulin Pump (MMT-1750)	Medtronic MiniMed, Inc.	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: 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: 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: Airway Exam Kit, DYKE1796	Medline Industries, LP	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: 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: 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: 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: 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: 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: 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: 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: Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)	Medtronic MiniMed, Inc.	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: Burlington Medical, Kilt Blockers.	Burlington Medical, LLC	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: 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: 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: 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: ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC	Medline Industries, LP	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: 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: 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: MiniMed 530G Insulin Pump (MMT-551, MMT-751)	Medtronic MiniMed, Inc.	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: 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: 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: 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: 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 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: 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: 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 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: 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: 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: 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: 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: 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: 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: 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: Burlington Medical, Thyroid Shield.	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, Blockers.	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, Caps.	Burlington Medical, LLC	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: Allura Xper FD20/15; System Code: 722058;	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; 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: 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: Vue Motion V12. Product Number: 1017979.	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: 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: MEDLINE ANTERIOR HIP PACK DYNJ64672B	Medline Industries, LP	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: 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: 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: 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: 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: CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-1	Mentor Texas, LP.	Class II	N/A
2026-04-01	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: 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: 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: 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: 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: 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: 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: Philips OMNI III TEE Ultrasound Transducer	Philips Ultrasound, Inc	Class III	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: 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: 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. 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: 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: 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: 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: DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H7871	Merit Medical Systems, Inc.	Class I	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: Philips Mini Multi TEE Ultrasound Transducer	Philips Ultrasound, Inc	Class III	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 3D6-2 Ultrasound Transducer	Philips Ultrasound, Inc	Class III	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: 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 X3-1 Ultrasound Transducer	Philips Ultrasound, Inc	Class III	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: 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: 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: 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: 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: Philips X7-2 Ultrasound Transducer	Philips Ultrasound, Inc	Class III	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: 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: 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: 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: 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: 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: 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: Philips L17-5 Ultrasound Transducer	Philips Ultrasound, Inc	Class III	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: 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: 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: 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: 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: 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: Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.	Olympus Corporation of the Americas	Class II	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: 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: Philips S4-1 Ultrasound Transducer	Philips Ultrasound, Inc	Class III	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: 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: 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
2026-03-25	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
2026-03-25	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: Cub Pediatric Crib, Model FL19H	Stryker Medical Division of Stryker Corporation	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: MICS3 Angled Sagittal Saw Attachment; Part Number: 210490	Howmedica Osteonics Corp.	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: 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: 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: 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 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: Battery Charging Station; Model: 0998-00-0802;	Datascope Corp.	Class III	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: Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm	ConvaTec, Inc	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
2026-03-18	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: 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 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: 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: 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
2026-03-18	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
2026-03-11	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-S Product Name: ShockPulse-SE Lithotripsy System -	Olympus Corporation of the Americas	Class II	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: 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: 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: Impella RP. Product Code: 0046-0011.	Abiomed, Inc.	Class I	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: CS300 IABP. Software Version CS300 IABP C.01.	Datascope Corp.	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: Impella RP with SmartAssist. Product Code: 0046-0035.	Abiomed, Inc.	Class I	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: 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: 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: EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5	Staar Surgical AG	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: 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: CS100 IABP. Software Version CS100 IABP Q.01.	Datascope Corp.	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: 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: 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: 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: Impella RP Flex with SmartAssist. Product Code: 1000323.	Abiomed, Inc.	Class I	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
2026-03-04	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: 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 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. 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.; Model No. A22043A. Resection sheath for urologic applications.	Olympus Corporation of the Americas	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: 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: 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: 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: 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: 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 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: 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: 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: 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: 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: 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: 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: Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214	Medline Industries, LP	Class II	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 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: PIE Trolley System Model: 2005	Edermy LLC	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: 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: 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: 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 Cystoscope Outer Sheath; Model/Catalog number: WA22810A;	Olympus Corporation of the Americas	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: Campy CVA Medium 100/PK, R01272	Remel, Inc	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: 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: PIE PAK Models: P2HC-A, P2HC-S, P2HC	Edermy LLC	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. 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: 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 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: 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, 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: 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: 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: Medline Convenience Kits: 1) NAIL KIT, Model Number: DYKM1528	Medline Industries, LP	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: Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1	Medtronic Perfusion Systems	Class II	N/A