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 3961–3980 of 38,428 recalls
Recalled Item: Leica Biosystems Cryostat Model Number CM1510 S
The Issue: As part of our post market surveillance, we
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Biosystems Cryostat Model Number CM1950
The Issue: As part of our post market surveillance, we
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triathlon Universal TS Baseplate Size 2 - A single use
The Issue: Anterior locking tabs on the Triathlon Universal Baseplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Insight Base Flex - 8
The Issue: The patient label stickers may have the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Centurion Sterile CirClamp
The Issue: Product has been identified as having holes in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Heathcare Giraffe OmniBed
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Heathcare Giraffe OmniBed Carestation
The Issue: GE HealthCare has become aware that for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for XR and 3.0T- For use as
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition S - For use as a diagnostic device
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T CX - For use as a diagnostic device
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evolution Upgrade 3.0T - For use as a diagnostic device
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition X- For use as a diagnostic device to
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for 1.5T - For use as a
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition X - For use as a diagnostic device
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to Ingenia Elition X - For use as a
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition S -For use as a diagnostic device to
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR 5300 - For use as a diagnostic device to obtain cross-sectional images
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR 7700 -For use as a diagnostic device to obtain cross-sectional images
The Issue: Integrated Radio Frequency (IRF) Carrier assembly screws may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.