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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 Devices·136,512 affected·Aug 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 Devices·1,167,120 affected·Aug 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 Devices·0 affected·Aug 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 Devices·106,176 affected·Aug 29, 2025
High RiskFDA
Getinge Disinfection Ab
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Medical Devices·902 affected·Aug 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 Devices·2,304 affected·Aug 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 Devices·958,351 affected·Aug 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 Devices·12,720 affected·Aug 29, 2025
High RiskFDA
Baxter Healthcare Corporation
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519
Medical Devices·18,720 affected·Aug 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 Devices·45 affected·Aug 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 Devices·27,072 affected·Aug 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 Devices·49,200 affected·Aug 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 Devices·15,552 affected·Aug 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 Devices·69,936 affected·Aug 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 Devices·586 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
Biograph mMR. Model Number: 10433372.
Medical Devices·27 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Verio. Model Number: 10276755.
Medical Devices·154 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Lumina (DE). Model Number: 11344916.
Medical Devices·130 affected·Aug 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 Devices·55 affected·Aug 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 Devices·3 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Medical Devices·39 affected·Aug 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 Devices·498 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Vida Fit. Model Number: 11410481.
Medical Devices·41 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Skyra fit. Model Number: 10849580.
Medical Devices·56 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Cima.X (DE). Model Number: 11647158.
Medical Devices·22 affected·Aug 28, 2025
CriticalFDA
Siemens Medical Solutions Usa, Inc
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Medical Devices·78 affected·Aug 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 Devices·56 affected·Aug 27, 2025
High RiskFDA
Osstem Implant Co., Ltd.
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
Medical Devices·0 affected·Aug 26, 2025
High RiskFDA
Osstem Implant Co., Ltd.
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
Medical Devices·0 affected·Aug 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 Devices·4,140 affected·Aug 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 Devices·29,225 affected·Aug 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 Devices·90 affected·Aug 22, 2025
High RiskFDA
Abbott Point Of Care Inc.
i-STAT EG6+ cartridge. List Number: 03P77-25.
Medical Devices·547,250 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S1, 12 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Medical Devices·3,790 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.914S1, 14 mm Distraction Pin, 5 single packs , Rx Only, Sterile
Medical Devices·2,700 affected·Aug 21, 2025
High RiskFDA
Abbott Point Of Care Inc.
i-STAT CG4+ cartridge (white). List Number: 03P85-25.
Medical Devices·9,067,050 affected·Aug 21, 2025
CriticalFDA
Medline Industries, Lp
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Medical Devices·828 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.916S1, 16 mm Distraction Pin, 10 single packs , Rx Only, Sterile
Medical Devices·490 affected·Aug 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 Devices·8,962,450 affected·Aug 21, 2025
High RiskFDA
Folsom Metal Products, Inc.
Frontier Devices, REF: 301.912S2, 12 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Medical Devices·160 affected·Aug 21, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U128, VALITUDE CRT-P EL MRI
Medical Devices·28,911 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U226, VISIONIST CRT-P EL
Medical Devices·1,050 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
PROPONENT SR SL (Model L200)
Medical Devices·1,380 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U228, VISIONIST CRT-P EL MRI
Medical Devices·41,191 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
ACCOLADE DR EL MRI (Model L331)
Medical Devices·34,180 affected·Aug 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 Devices·8 affected·Aug 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 Devices·1,980,000 affected·Aug 19, 2025
High RiskFDA
Boston Scientific Corporation
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Medical Devices·18 affected·Aug 18, 2025