Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
15,654 recalls
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Medical Devices136,512 affectedAug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 dro...
Medical Devices1,167,120 affectedAug 29, 2025
High RiskFDA
Bigtree Sales Inc.
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in ...
Medical Devices0 affectedAug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/...
Medical Devices106,176 affectedAug 29, 2025
High RiskFDA
Getinge Disinfection Ab
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Medical Devices902 affectedAug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (...
Medical Devices2,304 affectedAug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 dro...
Medical Devices958,351 affectedAug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0...
Medical Devices12,720 affectedAug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Medical Devices18,720 affectedAug 29, 2025
High RiskFDA
Imacor Inc.
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor mod...
Medical Devices45 affectedAug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLI...
Medical Devices27,072 affectedAug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CL...
Medical Devices49,200 affectedAug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch ...
Medical Devices15,552 affectedAug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve,...
Medical Devices69,936 affectedAug 29, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K...
Medical Devices586 affectedAug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
Biograph mMR. Model Number: 10433372.
Medical Devices27 affectedAug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Verio. Model Number: 10276755.
Medical Devices154 affectedAug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Lumina (DE). Model Number: 11344916.
Medical Devices130 affectedAug 28, 2025
High RiskFDA
Howmedica Osteonics Corp.
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
Medical Devices55 affectedAug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
Medical Devices3 affectedAug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Medical Devices39 affectedAug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425...
Medical Devices498 affectedAug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Vida Fit. Model Number: 11410481.
Medical Devices41 affectedAug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra fit. Model Number: 10849580.
Medical Devices56 affectedAug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Cima.X (DE). Model Number: 11647158.
Medical Devices22 affectedAug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Medical Devices78 affectedAug 28, 2025
High RiskFDA
Vision Rt Ltd
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Medical Devices56 affectedAug 27, 2025
High RiskFDA
Osstem Implant Co., Ltd.
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Medical Devices0 affectedAug 26, 2025
High RiskFDA
Osstem Implant Co., Ltd.
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Medical Devices0 affectedAug 26, 2025
High RiskFDA
Coopervision, Inc.
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, ...
Medical Devices4,140 affectedAug 22, 2025
High RiskFDA
Ge Medical Systems, Llc
MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001,...
Medical Devices29,225 affectedAug 22, 2025
High RiskFDA
Coopervision, Inc.
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moul...
Medical Devices90 affectedAug 22, 2025
High RiskFDA
Abbott Point Of Care Inc.
i-STAT EG6+ cartridge. List Number: 03P77-25.
Medical Devices547,250 affectedAug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Medical Devices3,790 affectedAug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Medical Devices2,700 affectedAug 21, 2025
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Medical Devices9,067,050 affectedAug 21, 2025
CriticalFDA
Medline Industries, Lp
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Medical Devices828 affectedAug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Medical Devices490 affectedAug 21, 2025
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
Medical Devices8,962,450 affectedAug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Medical Devices160 affectedAug 21, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U128, VALITUDE CRT-P EL MRI
Medical Devices28,911 affectedAug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U226, VISIONIST CRT-P EL
Medical Devices1,050 affectedAug 20, 2025
CriticalFDA
Boston Scientific Corporation
PROPONENT SR SL (Model L200)
Medical Devices1,380 affectedAug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U228, VISIONIST CRT-P EL MRI
Medical Devices41,191 affectedAug 20, 2025
CriticalFDA
Boston Scientific Corporation
ACCOLADE DR EL MRI (Model L331)
Medical Devices34,180 affectedAug 20, 2025
High RiskFDA
Microsurgical Technology Inc
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
Medical Devices8 affectedAug 20, 2025
High RiskFDA
Greiner Bio-one North America, Inc.
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner ...
Medical Devices1,980,000 affectedAug 19, 2025
High RiskFDA
Boston Scientific Corporation
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Medical Devices18 affectedAug 18, 2025