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 8961–8980 of 38,428 recalls
Recalled Item: Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital Care Products NEONATAL PICC TRAY
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHS Lacertaion Tray
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HCT 500mL BAGS
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Shein GLOVES
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case.
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tacy Medical
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Shein CYSTO SET UP PACK
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC KIT
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tacy Medical
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HCT CENTRAL LINE Insertion Tray
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GORE CARDIOFORM Septal Occluder
The Issue: Septal Occluders released with incomplete quality test documentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain
The Issue: Cardinal Health recently received multiple complaints regarding various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain
The Issue: Cardinal Health recently received multiple complaints regarding various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain
The Issue: Cardinal Health recently received multiple complaints regarding various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain
The Issue: Cardinal Health recently received multiple complaints regarding various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain
The Issue: Cardinal Health recently received multiple complaints regarding various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain
The Issue: Cardinal Health recently received multiple complaints regarding various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain
The Issue: Cardinal Health recently received multiple complaints regarding various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Jackson-Pratt Channel Drain
The Issue: Cardinal Health recently received multiple complaints regarding various
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.