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 12541–12560 of 38,428 recalls
Recalled Item: Quanta System Sterile Optical Laser Fiber
The Issue: Product sterility is potentially compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Concerto User Interface Software provided with the following systems: (1)
The Issue: If a saved treatment plan with 2 opposing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NES Reprocessed Visions PV .035 IVUS Catheter
The Issue: 510k indicated one (1) reprocessing cycle, product not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leccurate SARS-CoV-2
The Issue: Antigen Rapid Test Kit is not authorized, cleared,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atec Insignia Anterior Cervical Plate System
The Issue: There is a potential for the screw blocking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.