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 1641–1660 of 38,428 recalls
Recalled Item: Plastic Trial Head Brown
The Issue: Inconsistent size terminology and color coding used on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectrum IQ Infusion Pump
The Issue: Baxter has identified that certain pumps have potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMERICAN CONTRACT SYSTEMS
The Issue: During an internal investigation, ACS determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin Operating Tables Model Numbers: (1) 770001A0
The Issue: Under certain conditions, such as the simultaneous use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic
The Issue: Specific lots of reprocessed electrophysiology catheters may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMERICAN CONTRACT SYSTEMS
The Issue: During an internal investigation, ACS determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMERICAN CONTRACT SYSTEMS
The Issue: During an internal investigation, ACS determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMERICAN CONTRACT SYSTEMS
The Issue: During an internal investigation, ACS determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMERICAN CONTRACT SYSTEMS
The Issue: During an internal investigation, ACS determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMERICAN CONTRACT SYSTEMS
The Issue: During an internal investigation, ACS determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMERICAN CONTRACT SYSTEMS
The Issue: During an internal investigation, ACS determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMERICAN CONTRACT SYSTEMS
The Issue: During an internal investigation, ACS determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMERICAN CONTRACT SYSTEMS
The Issue: During an internal investigation, ACS determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Novum IQ Large Volume Pump
The Issue: Baxter is issuing an Urgent Medical Device Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3mensio Workstation (Vascular Fenestrated) software
The Issue: When fenestrated analysis with clock measurements is started
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
The Issue: Unidentified substance of unknown impact was identified on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
The Issue: Unidentified substance of unknown impact was identified on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
The Issue: Unidentified substance of unknown impact was identified on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum Duo Infusion System
The Issue: ICU Medical identified two sequences of programming events
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref:
The Issue: Laryngoscope handles may not illuminate as intended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.