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 11201–11220 of 38,428 recalls
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR superconducting magnets
The Issue: The magnetic resonance systems could potentially have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HYDRATOME RX 44-20MM/450CM Material Number: M00583060
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 44-20-260-035 Material Number: M00573040
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 49-20MM/260CM Material Number: M00583000
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/260CM Material Number: M00584050
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: JAGTOME RX 39-20-450-025 Material Number: M00573090
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 39-20-260-025 Material Number: M00584240
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/260CM Material Number: M00584000
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/450CM Material Number: M00584030
The Issue: Sterility of device is compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.