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 25661–25680 of 38,428 recalls
Recalled Item: Weck Facial Closure Systems have application in laparoscopic procedures for
The Issue: The devices wings may become partially detached from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImplantDirect Legacy 4 Implant
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modular Necks: The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems
The Issue: All lots of modular neck hip prostheses are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM)
The Issue: All lots of modular neck hip prostheses are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems
The Issue: All lots of modular neck hip prostheses are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARPAL TUNNEL PACK
The Issue: Covidien issued a labeling update for the Covidien
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SET UP PACK Surgical Instrument Tray
The Issue: Covidien issued a labeling update for the Covidien
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BREAST PACK
The Issue: Covidien issued a labeling update for the Covidien
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS System
The Issue: Software update that provides software and firmware bug-fixes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Edge System
The Issue: Software update that provides software and firmware bug-fixes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Flash System
The Issue: Software update that provides software and firmware bug-fixes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cellfina Prep Pack
The Issue: It was discovered that a non-sterile vacuum tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Spectral CT Applications supports viewing and analysis of images
The Issue: A software defect is causing issues with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IQon Spectral CT is a Computed Tomography X-Ray System intended
The Issue: A software defect is causing issues with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce
The Issue: Software error due to the filament on timer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 728231 Computed Tomography X-ray systems intended to produce
The Issue: Software error due to the filament on timer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce
The Issue: Software error due to the filament on timer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128 728323
The Issue: Software error due to the filament on timer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 728232 Computed Tomography X-ray systems intended to produce
The Issue: Software error due to the filament on timer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.