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 161–180 of 38,428 recalls
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number:...
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided)
The Issue: Devices which did not undergo thermoforming could deform
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.