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 29641–29660 of 38,428 recalls
Recalled Item: KNEE ARTHROSCOPY PK 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: GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED 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: LAP-CHOLECYSTECTOMY SURGICAL PACK 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: PREMIUM CESAREAN PACK 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: SUTURE REMOVAL KIT CUSTOMED 100/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: LAPAROSC. OB GYN PK 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: SUCTION CATHETER KIT 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: TRACHEOTOMY CARE KIT 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: GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED 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: OPEN HEART TRAY CUSTOMED 1/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: (1) (2) 10/CS CUSTOMED 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: EAR 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: ARTHROSCOPY SURGICAL PACK 4/C 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-TPSC 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: ARTHROSCOPY 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: C-SECTION PK 2/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: OPEN HEART TRAY 1/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: SHOULDER 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: ORTHOPEDIC PACK BASIC 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: LAPAROSCOPY CHOLE 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.