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 23001–23020 of 38,428 recalls
Recalled Item: REVOLVE ADVANCED ADIPOSE SYSTEM
The Issue: Presence of bacterial endotoxins levels above the acceptable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Custom Pak
The Issue: Alcon is initiating a medical device recall, after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skintact Electrode for Defibrillation
The Issue: Certain lots of the defibrillation electrodes model DF59N
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Unity software
The Issue: The software is not identifying the patient as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Stemmed Tibial Provisional Size H Right
The Issue: There is a potential for intermittent cracks in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Cemented Tibial SZ PLT Size H Left
The Issue: There is a potential for intermittent cracks in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Stemmed Tibial Provisional Size H Left
The Issue: There is a potential for intermittent cracks in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Cemented Tibial SZ PLT Size H Right
The Issue: There is a potential for intermittent cracks in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001
The Issue: May have difficulty attaching the drill sleeve to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail
The Issue: During the rework process for the April 17,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail
The Issue: During the rework process for the April 17,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Emprint Percutaneous Antenna with Thermosphere Technology
The Issue: The firm received consumer reports of the ceramic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Emprint Percutaneous Antenna with Thermosphere Technology
The Issue: The firm received consumer reports of the ceramic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Emprint Percutaneous Antenna with Thermosphere Technology
The Issue: The firm received consumer reports of the ceramic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Emprint Percutaneous Antenna with Thermosphere Technology
The Issue: The firm received consumer reports of the ceramic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Emprint Percutaneous Antenna with Thermosphere Technology
The Issue: The firm received consumer reports of the ceramic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Emprint Percutaneous Antenna with Thermosphere Technology
The Issue: The firm received consumer reports of the ceramic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail
The Issue: During the rework process for the April 17,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail
The Issue: During the rework process for the April 17,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affixus Hip Fracture Nail
The Issue: During the rework process for the April 17,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.