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 35141–35160 of 38,428 recalls
Recalled Item: Zoll Circulation LifeBand Single Pack (accessory)
The Issue: Typographical error in the Japanese legal label of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT and Brilliance iCT SP These systems are intended
The Issue: An artifact that resembles thrombus may appear on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemoCue¿ Urine Albumin Microcuvettes
The Issue: HemoCue AB has become aware of a production
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UNITRAC Pneumatic Retraction Arm. A support arm used to hold
The Issue: Changes were implemented to the UNITRAC instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards EndoReturn Arterial Cannula
The Issue: Edwards Lifesciences is recalling certain lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality
The Issue: The products may have been stored at temperatures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProTime Microcoagulation System
The Issue: The products may have been stored at temperatures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemoccult II BRAND SENSA elite
The Issue: The products may have been stored at temperatures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS
The Issue: The trial stems were manufactured using the wrong
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.