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 12861–12880 of 38,428 recalls
Recalled Item: Cardiosave Hybrid IABP - Product Usage: used to inflate and
The Issue: There are cybersecurity vulnerabilities in a widely used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Univation X System knee implant devices as follows: Catalog/Product: NL470
The Issue: Malfunction- loosening of the implant resulting in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Univation X System knee implant devices as follows: Catalog/Product: NO156Z
The Issue: Malfunction- loosening of the implant resulting in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Univation X System knee implant devices as follows: Catalog/Product: NL494
The Issue: Malfunction- loosening of the implant resulting in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Univation X System knee implant devices as follows: Catalog/Product: NO180Z
The Issue: Malfunction- loosening of the implant resulting in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Univation X System knee implant devices as follows: Catalog/Product: NL476
The Issue: Malfunction- loosening of the implant resulting in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Univation X System Tray Sysem knee implant devices as follows:
The Issue: Malfunction- loosening of the implant resulting in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Univation X System knee implant devices as follows: Catalog/Product: NL488
The Issue: Malfunction- loosening of the implant resulting in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Univation X System knee implant devices as follows: Catalog/Product: NL482
The Issue: Malfunction- loosening of the implant resulting in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution CT
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer - Product Usage: intended to assist in the viewing
The Issue: When the Cross Enterprise Display option is enabled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS...
The Issue: Siemens has become aware of a potential issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protek Solo Venous Dilator Set: dilator
The Issue: On 02/26/2021, it was found that there were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte
The Issue: Users may observe additional locus specific signals at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectrum IQ - Infusion Pump - Product Usage: intended to
The Issue: Potentially defective component in the AC power adapter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK Endo-Model Modular Knee Prosthesis System Femoral Segment
The Issue: The firm discovered through customer complaints that device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK Endo-Model Modular Knee Prosthesis System Femoral Segment
The Issue: The firm discovered through customer complaints that device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK Endo-Model Modular Knee Prosthesis System Femoral Segment
The Issue: The firm discovered through customer complaints that device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK Endo-Model Modular Knee Prosthesis System Femoral Segment
The Issue: The firm discovered through customer complaints that device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentueri Viral Transport Medium (VTM)
The Issue: Medium showed visual turbidity and discoloration, potentially contaminating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.