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 10001–10020 of 38,428 recalls
Recalled Item: Lunderquist -Ring Torque Wire Guide
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Movable Core Wire Guide (Tefcor)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bentson Wire Guide
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coons Interventional Wire Guide
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner PC Wire Guide (Nimble Floppy)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fixed Core Wire Guide (Straight)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PTS Panels CHOL+GLU Test Strips ()
The Issue: Incorrect instructions for use were packaged into the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner PC Wire Guide (Nimble)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cope Mandril Wire Guide (Nitinol)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURGIMESH WN
The Issue: presence of residual adhesive material on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURGIMESH XB
The Issue: presence of residual adhesive material on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURGIMESH XB
The Issue: presence of residual adhesive material on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURGIMESH WN
The Issue: presence of residual adhesive material on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sedecal Soltus Battery Mobile X-Ray System 450 Battery
The Issue: Due to un-commanded movement of mobile x-ray unit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR Acetabular System
The Issue: Hip liner implant boxes may contain knee inserts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWER 3D Knee Tibial Insert
The Issue: Hip liner implant boxes may contain knee inserts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COVID Test Kit Nonsterile
The Issue: Kit incorrectly labeled for use with COVID testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Humidifier bottle and syringe filter kit (6 count of each)
The Issue: There is a potential breach to the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Humidifier bottle and syringe filter kit (6 count of each)
The Issue: There is a potential breach to the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.