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 15661–15680 of 38,428 recalls
Recalled Item: Chemistry QC Premium Plus
The Issue: The control target and range value for Sodium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure trays containing medical components needed to facilitate...
The Issue: The medical procedure trays contain one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure trays containing medical components needed to facilitate...
The Issue: The medical procedure trays contain one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure trays containing medical components needed to facilitate...
The Issue: The medical procedure trays contain one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure trays containing medical components needed to facilitate...
The Issue: The medical procedure trays contain one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure trays containing medical components needed to facilitate...
The Issue: The medical procedure trays contain one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure trays containing medical components needed to facilitate...
The Issue: The medical procedure trays contain one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure trays containing medical components needed to facilitate...
The Issue: The medical procedure trays contain one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure trays containing medical components needed to facilitate...
The Issue: The medical procedure trays contain one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom procedure trays containing medical components needed to facilitate...
The Issue: The medical procedure trays contain one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AB HiResolution Bionic Ear System
The Issue: hearing performance degradation due to body-fluid entering the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AB HiResolution Bionic Ear System
The Issue: hearing performance degradation due to body-fluid entering the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChemVELOCITY Strips
The Issue: The Leukocyte and Compensation pads were switched on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Shoulder System Mini Humeral Stem 9mm
The Issue: A 15mm Shoulder Mini Humeral Stem was misidentified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Cogent Hemodynamic Monitoring System.
The Issue: Firm identified software issues which leads to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
The Issue: Embolization device delivery system may fracture at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare...
The Issue: There is a software issue which may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Ethyl Alcohol
The Issue: The assay may exhibit a positive bias in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS.
The Issue: Embolization device delivery system may fracture at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q.zen Biplane
The Issue: A software issue could potentially cause the stand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.