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 10321–10340 of 38,428 recalls
Recalled Item: Merlin 2 PCS MER37000 programmer Model MER3400 software
The Issue: The Merlin" 2 PCS model MER3700 is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin PCS 3650 programmer Model 3330 software
The Issue: There is a potential for programmer software (Merlin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin.net model MN5000 Software
The Issue: The Merlin" 2 PCS model MER3700 is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERIGENE Enteric Pathogens Nucleic Acid Test
The Issue: There is a potential for false negative results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various ob/gyn packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Angiography packs/trays
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breast Abdominoplasty Pack
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various C-section packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various convenience packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various convenience packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D&C pack
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Port Insertion Packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various eye packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various neurology packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Pacemaker Packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various ENT Packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Angiography/Cath Lab packs/trays
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Cysto Packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various hysterectomy
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Laparoscopy Packs
The Issue: Product was exposed to multiple sterilization cycles without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.