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 32001–32020 of 38,428 recalls
Recalled Item: Laparotomy Pack 1 (2 &
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Angiography Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hair Restoration Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACDF Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cesarean Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Drainage Tray
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparotomy Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgeon Gown Poly Reinforced Lgc
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shoulder Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minor Laceration Tray
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O.B. Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breast Pack Used by medical staff to perform patient care
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wound Closure Tray II
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparoscopy Chole Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laminectomy Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Premium Laparotomy Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plastic Surgery Pack
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparotomy Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gown Fabric Reinforced XXL
The Issue: Customed products are being recalled because of compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tummy Tuck Pack
The Issue: Significant compromised sterility, not limited to potentially damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.