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 24481–24500 of 38,428 recalls
Recalled Item: Healon Pro
The Issue: Remote possibility that certain solutions in these lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healon 5 Pro
The Issue: Remote possibility that certain solutions in these lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healon
The Issue: Remote possibility that certain solutions in these lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healon Duet
The Issue: Remote possibility that certain solutions in these lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Healon V
The Issue: Remote possibility that certain solutions in these lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arctic Sun 5000 Temperature Management System
The Issue: failure of the Arctic Sun 5000 Temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATAR Disposable Extension Cable
The Issue: The Reusable Oscor ATAR extension cables could separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATAR Reusable Extension Cable
The Issue: The Reusable Oscor ATAR extension cables could separate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endopath ETS-FLEX Endoscopic Articulating Linear Cutter
The Issue: There is a risk that the pinion gear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi EndoWrist Suction Irrigator
The Issue: Intuitive Surgical has become aware that in specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optional MDRC-1119 Front Cover Attachment Kit for review display monitors.
The Issue: If metal strips are removed and re-applied to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate¿ II LVAS with Pocket Controller
The Issue: St. Jude Medical is providing all users of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate¿ II LVAS with Pocket Controller
The Issue: St. Jude Medical is providing all users of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate¿ II LVAS with Pocket Controller
The Issue: St. Jude Medical is providing all users of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA
The Issue: Packaging error. 20GA Vitrectomy Cutters may be found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENOVATION
The Issue: The stability data does not support the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dressing Knee/Shldr
The Issue: They may not have been sealed prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dressing Shldr XL
The Issue: They may not have been sealed prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dressing M/U XL
The Issue: They may not have been sealed prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.