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 1781–1800 of 38,428 recalls
Recalled Item: Ingenia 1.5T Model Numbers (REF): (1) 781315
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR 7700 Model Numbers (REF): (1) 782120
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED
The Issue: Cannulated fenestrated polyaxial screws may be incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DreamStation Auto BiPAP. Non-Continuous Ventilator.
The Issue: Devices may possess a programming error resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DreamStation Auto. Non-Continuous Ventilator.
The Issue: Devices may possess a programming error resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED
The Issue: Cannulated fenestrated polyaxial screws may be incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DreamStation Auto CPAP. Non-Continuous Ventilator.
The Issue: Devices may possess a programming error resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition X Model Numbers (REF): (1) 781358
The Issue: The potential for component failures in the Gradient
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 potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T S Model Number (REF): 781347
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T Model Numbers (REF): (1) 781342
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR 5300 Model Numbers (REF): (1) 782110
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition S Model Numbers (REF): (1) 781359
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 3.0T
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Upgrade to MR 7700 Model Number (REF): 782130
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T CX Model Numbers (REF): (1) 781271
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition S Model Numbers (REF): (1) 781357
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva XR
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118
The Issue: The potential for component failures in the Gradient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.