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 15241–15260 of 38,428 recalls
Recalled Item: Formula 418 Renal Balloon-Expandable Stent
The Issue: The firm received complaints on five devices from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SureStep Foley Tray System - Product Usage: Intended for use
The Issue: There is potential for a white paper-type residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for
The Issue: May exhibit increased levels of artifacts which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBLTM Gram Crystal Violet 3.8L-- IVD Primary stain for
The Issue: May exhibit increased levels of artifacts which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBLTM Gram Stain Kit with Stabilized Iodine-- IVD For
The Issue: May exhibit increased levels of artifacts which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The
The Issue: The labeling of the Philips Chest Pneumograph does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Custom Packs to be used in surgical procedures.
The Issue: The surgical gowns were manufactured in a facility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiovascular Monitoring Device accessory - Product Usage: The chest...
The Issue: The labeling of the Philips Chest Pneumograph does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.