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 35161–35180 of 38,428 recalls
Recalled Item: BRAINLAB
The Issue: The Frameless SRS QA Target Pointer - Pointer
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: Moore Hip Prosthesis Long Fenestrated Stem
The Issue: Zimmer recently conducted a review of historic packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PleuraGuide Disposable Chest Tube Kit
The Issue: Individual component's IFUs are not included with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy
The Issue: Failure to provide calibration procedures to purchasers, as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOPLUS
The Issue: Multiple complaints reporting that the moveable jaw has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOPLUS
The Issue: Multiple complaints reporting that the moveable jaw has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemoCue¿ Glucose 201 Microcuvettes
The Issue: During a complaint investigation HemoCue AB discovered punctured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Insufflation Tubing sets: 1) Insufflation Tubing
The Issue: DeRoyal Industries is recalling their product Insufflation Tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: Boston Scientific CRM manufacturing quality system recently discovered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number:
The Issue: Reports of false abnormally high glucose readings from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Max Glucose Test Strips (50 Count International Catalog Number:
The Issue: Reports of false abnormally high glucose readings from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.