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 29601–29620 of 38,428 recalls
Recalled Item: SHOULDER PACK 6/CS Used by medical staff to perform surgical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARPAL TUNEL LARGE SURGICAL PACK
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UROLOGY SURGICAL PACK 6/CS Used by medical staff to perform
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BREAST PACK-BOD 6/CS Used by medical staff to perform surgical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAPAROTOMY PACK 3/CS Used by medical staff to perform surgical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LABOR & DELIVERY 4/CS Used by medical staff to perform
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MINOR PACK 4/CS Used by medical staff to perform surgical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENERAL MINOR PK 5/CS Used by medical staff to perform
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HIP ORTHO. PACK 3/CS Used by medical staff to perform
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UTILITY DRAPE END PRODUCT 50PK/CS 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: PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS 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: MINOR LACERATION TRAY CUSTOMED 50/CS 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: UROLOGY PACK 4/CS Used by medical staff to perform surgical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURG GOWN POLYREINF LGE CUSTOM 28/CS 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: WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER 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: WOUND CLOSURE TRAY I CUSTOMED 50/CS 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: GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS 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: LAPAROSCOPY PACK 6/CS Used by medical staff to perform surgical
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LABOR & DELIVERY 4/CS Used by medical staff to perform
The Issue: Recall initiated due to inadequate validation/qualification of sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.