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 28261–28280 of 38,428 recalls
Recalled Item: Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900012 OB SURGICAL PACK Used by medical staff
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 9002899 CYSTO TUR SURGICAL PACK Used by medical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900740A ARTHROSCOPY SURGICAL PACK Used by medical staff
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by...
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.