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 19421–19440 of 38,428 recalls
Recalled Item: Vanguard Knee System -PS Open Box Femoral Right
The Issue: Label on the outer carton or the patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5
The Issue: Software anomaly may incorrectly extend the on-analyzer stability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ 3600 Immunodiagnostic System
The Issue: Software anomaly may incorrectly extend the on-analyzer stability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System
The Issue: Software anomaly may incorrectly extend the on-analyzer stability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System
The Issue: Software anomaly may incorrectly extend the on-analyzer stability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray
The Issue: Vibrations of the C-arm of the plane B
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS Q biplane with Material 10848282- - a Angiographic x-ray
The Issue: Vibrations of the C-arm of the plane B
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray
The Issue: Vibrations of the C-arm of the plane B
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChem VELOCITY Urine Chemistry Strips
The Issue: Falsely elevated (false positive) urobilinogen patient results due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 6 Slice (Air)
The Issue: There is a potential for separation of fiberglass
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 40
The Issue: There is a potential for separation of fiberglass
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 16 Slice (Power)
The Issue: There is a potential for separation of fiberglass
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64
The Issue: There is a potential for separation of fiberglass
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 10 Slice (Air)
The Issue: There is a potential for separation of fiberglass
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 16 Slice (Air)
The Issue: There is a potential for separation of fiberglass
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture.
The Issue: Incorrect measurement results caused by microbial contamination of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture
The Issue: Incorrect measurement results caused by microbial contamination of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1 Electronic Patient Gas System (EPGS)
The Issue: An intermittent failure which causes a blender initialization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Richard Wolf Bronchoscope Tubes
The Issue: There is a potential deficiency of the TEXAS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visions PV .035 Digital IVUS Catheter
The Issue: Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.