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 9701–9720 of 38,428 recalls
Recalled Item: regard MINOR DAVINCI PACK
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard VITRECTOMY PK
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard KYPHOPLASTY
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard SPINE PACK
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard PEDIATRIC UROLOGY
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard NEURO TRAY
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard LAMINECTOMY
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard VITRECTOMY PACK
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard MAJOR CRANI
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ¿regard EYE TRAY
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard SPINE PACK
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ¿regard SHOULDER PK
The Issue: Surgical convenience kits were distributed containing 3M surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEO-fit Neonatal Endotracheal Tube Grip
The Issue: Firm has received 11 complaints involving a loose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMV IgM EIA
The Issue: Due to an unusual increase in the positivity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
The Issue: Warehouse experienced temperature excursions in July and August
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom Progressa Bed System
The Issue: The compression links on impacted Progressa beds, listed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AC3 Optimus Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AC3 Optimus Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump
The Issue: There is a potential issue with short battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.