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 401–420 of 38,428 recalls
Recalled Item: Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography
The Issue: AIRO pendant replacement kits and upgrade do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abre Venous Self-Expanding Stent System
The Issue: Stents may be impacted by a Nitinol anomaly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 with SmartAssist¿ S2
The Issue: Device packaged in incorrect outer box carton
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition S. Product Code (REF): 782108. MR systems with
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T. Product Code (REF): (1) 781342
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR 7700. Product Code (REF): (1) 782120
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition X. Product Code (REF): (1) 781358
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for XR and 3.0T. Product Code (REF):
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition X. Product Code (REF): (1) 781356
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Elition S. Product Code (REF): (1) 781357
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Upgrade to MR 7700. Product Code (REF): 782130. MR systems
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T. Product Code (REF): (1) 781341
The Issue: The potential for stiffness value errors when viewing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and
The Issue: Complaints received that Vanta A71200 CP App does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter
The Issue: Boston Scientific is initiating the removal of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Incisive CT
The Issue: for incomplete scan due to unstable connection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis ES Enterprise Server Catalog Numbers 1115-00
The Issue: Due a software issue that may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.