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 3741–3760 of 38,428 recalls
Recalled Item: medex TranStar Disposable Transducer 1/EA
The Issue: Due to a manufacturing defect, users may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with
The Issue: Due to a manufacturing defect, users may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KLS Martin Battery Pack
The Issue: The packaging of a sterile battery, intended to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS
The Issue: challenge with intraoperative assembly of the external
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard KIT
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard KIT
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard KIT
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard KIT
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard CPT PEDS ADULT CH PACK - Medical convenience kits
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number:
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard OPEN HEART PACK MAIN - Medical convenience kits Model
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number:
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.