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 28281–28300 of 38,428 recalls
Recalled Item: Catalog Number: 9001294 PREMIUM CESAREAN 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: 900996 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.
Recalled Item: Catalog Number: 9002224 SURGICAL 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: 9001061 PERI-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: 9001297 PREMIUM OBSTETRICAL 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: 900484 LAPAROSCOPIC GYNECOLOGY 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: 9002256 NEUROSURGERY 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: 900281A LAPAROTOMY 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: 9001300 NEURO-SPINE 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: 900521 SURGICAL GOWN SMS POLY-REINFORCED
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: 9001765 MINOR LACERATION 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: 900052 MINOR PROCEDURE 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: 900474 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: 9001496 D&C LAPAROSCOPY 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: 900998 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: 9002123 KNEE ARTHROSCOPY 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: 9001966 LIVER & PANCREAS SURGERY 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: 9001062 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: 900080 CYSTOSCOPY 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: 9002829 BASIC SURG 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.