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 29581–29600 of 38,428 recalls
Recalled Item: OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected.
The Issue: OmniPods¿ (Pods) have a higher rate of failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected.
The Issue: OmniPods¿ (Pods) have a higher rate of failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Intended
The Issue: Electrostatic energy may be stored in Systems that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PS500 of an IACS Workstation Critical Care (Evita Infinity V500)
The Issue: The battery capacity of the optional PS500 of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Etac Relax wall mounted shower seat The Etac Relax is
The Issue: The recalling firm has received reports of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUMBAR 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: FACE PACK MRT 8/CS CUSTOMED 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: CESAREAN PACK 5/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: CESAREAN 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: MINOR LAPAROTOMY 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: CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/CS 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: FACE PACK FJG 8/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: 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: PEDIATRIC LAP PACK 8/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: FEMORAL PACK 5/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 CS/6 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: OB PACK CS/4 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: E.N.T. PK 7/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: FEMORAL 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: IMPLANTE DE ORTHOPEDIA 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.