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 11221–11240 of 38,428 recalls
Recalled Item: JAGTOME RX 49-20-260-035 Material Number: M00573000
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DREAMTOME 44-30MM/450CM Material Number: M00584070
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321...
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYDRATOME RX 44-20MM/260CM Material Number: M00583040
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DREAMTOME 49-30MM/260CM Material Number: M00584010
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material...
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYDRATOME RX 49-30MM/260CM Material Number: M00583010
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAGTOME RX 44-30-260-035 Material Number: M00573060
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAGTOME RX 39-30-450-025 Material Number: M00573110
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAGTOME RX 44-30-450-035 Material Number: M00573070
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAGTOME RX 44-20-450-035 Material Number: M00573050
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAGTOME RX 39-30-260-025 Material Number: M00573100
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYDRATOME RX 44-30MM/450CM Material Number: M00583070
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAGTOME RX 39-20-260-025 Material Number: M00573080
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DREAMTOME 49-20MM/450CM Material Number: M00584020
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material...
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAGTOME RX 49-30-450-035 Material Number: M00573030
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.