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 2801–2820 of 38,428 recalls
Recalled Item: BORN ON ARRIVAL KIT
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: URO ROBOTIC PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENERAL ANGIO PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-SECTION PPS
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AV FISTULA
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THORACIC PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: Beckman Coulter identified that an issue for DxI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis: Anesthesia Station ES
The Issue: Sync timeout may occur between the server and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPEN HEART A PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CV BASIC PUMP PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAJOR DIEP
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPINE LUMBAR PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEURO IR TRAY
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EAR PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAPAROSCOPY PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAPAROSCOPY PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TOTAL HIP PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AURORA Surgiscope System
The Issue: Possibility for the obturator to break (separate)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDITECH Expanse Laboratory (LAB)
The Issue: Entering multiple keys that trigger input simultaneously may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: the DxI 9000 encoder wheel was misaligned on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.