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 21581–21600 of 38,428 recalls
Recalled Item: Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults
The Issue: After two and a half years, the battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoenix Nail System
The Issue: Certain lots of the Phoenix Tibia Nail 3.5mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RICHARD WOLF TUBE SET FOR TEM
The Issue: Tube ends may be mixed up
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-C3 Ventilator Unit Product Usage: The HAMILTON-C3 ventilator is...
The Issue: An out of specification component on the control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-C1 Ventilator Unit Product Usage: The HAMILTON-C1 ventilator is...
The Issue: An out of specification component on the control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6381 M-1 Cot Fastener
The Issue: The Operations Manual and Maintenance Manual are missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6376 M-1 Cot Fastener
The Issue: The Operations Manual and Maintenance Manual are missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Binding Site Optilite Beta-2-Microglobulin Urine Kit
The Issue: The product is not meeting the antigen excess
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim DRG Implantable Pulse Generator
The Issue: The firm received complaints of error messages that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOUTHERN IMPLANTS
The Issue: The UDI label correctly reads IBR12d-13, however, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences EZ Glide Aortic Cannula
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Femoral Venous Cannula
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Avid Dual Stage Venous Drainage Cannula
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Aortic Perfusion Cannula
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic...
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding Stent
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic...
The Issue: The expiration date on the device labeling exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.