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 1421–1440 of 38,428 recalls
Recalled Item: Frontier Devices
The Issue: Labeling includes shelf life that has not been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT EG7+ cartridge. List Number: 03P76-25.
The Issue: Lack of a 510(k) premarket clearance for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MST ArcDUO 9mm
The Issue: An ophthalmic knife has a suction set (not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L211 PROPONENT DR SL MRI Pacemaker
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number S702
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number U128
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L101
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L121 ESSENTIO DR EL Pacemaker
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L210 PROPONENT SR SL Pacemaker
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L231
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L100
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L209 PROPONENT DR (VDD) SL Pacemaker
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number U226
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROPONENT SR SL (Model L200)
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number U228
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L221 PROPONENT DR EL Pacemaker
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L131
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE DR EL MRI (Model L331)
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L110
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number U225 VISIONIST CRT-P EL
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.