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 13921–13940 of 38,428 recalls
Recalled Item: DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in
The Issue: Due to footswitch not meeting required specification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector
The Issue: Detachment of the Male AIV Adaptor from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Ultrasound Endoscope
The Issue: A new inspection step was added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Ultrasound Endoscope
The Issue: A new inspection step was added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Ultrasound Endoscope
The Issue: A new inspection step was added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Ultrasound Endoscope
The Issue: A new inspection step was added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Ultrasound Endoscope
The Issue: A new inspection step was added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Ultrasound Endoscope
The Issue: A new inspection step was added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Ultrasound Endoscope
The Issue: A new inspection step was added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Ultrasound Endoscope
The Issue: A new inspection step was added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Ultrasound Endoscope
The Issue: A new inspection step was added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Ultrasound Endoscope
The Issue: A new inspection step was added to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use
The Issue: Product instability; biased ALKP values obtained from VITROS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for
The Issue: In-house lab observations and customer reports of overheating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Zyphr Disposable Cranial Perforator
The Issue: for the inner bit to contain a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous...
The Issue: 5F Micro-Introducer Kits may not contain the correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Processor SP
The Issue: Luminex has determined that three (3) separate test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Processor SP
The Issue: Luminex has determined that three (3) separate test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard - Product Usage: Obstetric Gynecologic specialized manual instrument....
The Issue: Labeling error, incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardioblate CryoFlex
The Issue: There is a potential defect in the seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.