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 3261–3280 of 38,428 recalls
Recalled Item: Otological Ventilation Tube - T-Tube 6mm - Double - Silicone
The Issue: Lack of 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otological Ventilation Tube - Donaldson - Blue Silicone
The Issue: Lack of 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otological Ventilation Tube - T-Tube 9mm - Double - Silicone
The Issue: Lack of 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otological Ventilation Tube - T-Tube 12mm - Silicone
The Issue: Lack of 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otological Ventilation Tube - T-Tube 6mm - Silicone
The Issue: Lack of 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otological Ventilation Tube - T-Tube 12mm - Double - Silicone
The Issue: Lack of 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Otological Ventilation Tube - Donaldson - Double - Blue Silicone
The Issue: Lack of 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Medical Biodesign Hiatal Hernia Graft
The Issue: Incorrect version of IFU was used rather than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Medical Biodesign Otologic Butterfly Graft
The Issue: Incorrect version of IFU was used rather than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Medical Biodesign Dural Graft
The Issue: Incorrect version of IFU was used rather than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc NXS Host
The Issue: Siemens Healthcare Diagnostics is recalling their epoc Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc NXS Host
The Issue: Siemens Healthcare Diagnostics is recalling their epoc Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clarity Precision Grip Attachments
The Issue: Attachments may not mate with the tooth as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc NXS Host
The Issue: Siemens Healthcare Diagnostics is recalling their epoc Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc NXS Host
The Issue: Siemens Healthcare Diagnostics is recalling their epoc Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc NXS Host
The Issue: Siemens Healthcare Diagnostics is recalling their epoc Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc NXS Host
The Issue: Siemens Healthcare Diagnostics is recalling their epoc Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc NXS Host
The Issue: Siemens Healthcare Diagnostics is recalling their epoc Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc NXS Host
The Issue: Siemens Healthcare Diagnostics is recalling their epoc Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.