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 5101–5120 of 38,428 recalls
Recalled Item: ADVANTA VXT
The Issue: Complaints of reported separation of the Slider GDS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 3.0T Model Number (REF): (1) 781345
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition S Model Number (REF): (1) 782139
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for 3.0T Model Number (REF): 782145
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evolution upgrade 3.0T Model Number (REF): (1)782117
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T Initial system Model Number (REF): 781178
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR RT - Magnetic Resonance (MR) systems are Medical Electrical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T Model Number (REF): (1) 782140
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems
The Issue: The g-MDU (global Mains Distribution Unit) L3 terminal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cerene Cryotherapy Device Product Name: DEVICE
The Issue: Error code 003 was not listed in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.