Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 4881–4900 of 38,428 recalls
Recalled Item: Abbott Infinity 5
The Issue: Their is a potential that the implantable pulse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Infinity 7
The Issue: Their is a potential that the implantable pulse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo Model SL Tibial Components 16-2817/02 Tibial Component
The Issue: Blind screws of the modular tibial component cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endo Model M Tibial Components Modular Knee Prosthesis System. Product
The Issue: Blind screws of the modular tibial component cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the...
The Issue: for inaccurate fetal heart rate measurements when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2nd Generation CentriMag Primary Console
The Issue: Due to a component change, the console part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prelude Roadster Guide Sheath -PG4F90S -PG5F45MP -PG5F45R -PG5F45S
The Issue: Due to older version of Instruction for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products FS Diluent Pack 3
The Issue: VITROS Chemistry Products FS Diluent Pack 3, Lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris System Manager
The Issue: Due to a software issue the PC unit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IsoLoc Prostate Immobilization Treatment Balloon Device Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pink Luminous Breast
The Issue: Firm is marketing and distributing the Pink Luminous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cascade IOMAX Cortical Module
The Issue: Electroneurodiagnostic medical device may contain a defective printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fathom Pedicle-Based Retractor Product Name: C/C Blade
The Issue: Cranial Caudal Blades manufactured incorrectly could result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fathom Pedicle-Based Retractor Product Name: C/C Blade
The Issue: Cranial Caudal Blades manufactured incorrectly could result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VASOVIEW HemoPro 2 Endoscopic Vessel Harvesting System
The Issue: for there to be a fluid ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA)
The Issue: Siemens Healthineers has identified an issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RingLoc Bi-Polar Hip System Acetabular Cup
The Issue: 41 mm acetabular outer heads were potentially assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VASOVIEW HemoPro Endoscopic Vessel Harvesting Systems are designed for
The Issue: for there to be a fluid ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stimuplex A
The Issue: The devices are labeled "not made with DEHP"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stimuplex A
The Issue: The devices are labeled "not made with DEHP"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.