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 25721–25740 of 38,428 recalls
Recalled Item: Novation Cemented Plus Femoral Stem
The Issue: Products were labeled with incorrect Global Trade Item
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is
The Issue: BD is conducting a voluntary product recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TENNIS ELBOW SUPPORT
The Issue: DeRoyal received complaints of mold on Tennis Elbow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PNEUGEL(R) TENNIS ELBOW STRAP
The Issue: DeRoyal received complaints of mold on Tennis Elbow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems
The Issue: Firm received reports about "acquisition errors" and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a
The Issue: The firm failed to notify current customers of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VOCO Futurabond M+ adhesive
The Issue: Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HF Cable WA00014A
The Issue: Software malfunction that results in incorrect generation or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adiprep Adipose Transfer System. Product Codes: 51431
The Issue: Terumo BCT announces a voluntary field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System
The Issue: Incorrect Dose when using the reset function
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Flash
The Issue: Siemens is releasing a software update that provides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Edge
The Issue: Siemens is releasing a software update that provides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS
The Issue: Siemens is releasing a software update that provides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris System PC unit
The Issue: Reports where the Low Battery alarm and/or the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IVEA 500A Intended for Med-Surg patient care.
The Issue: The dowel pin could potentially slip out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
The Issue: Package may be incorrectly labeled as containing 0.76
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q
The Issue: The possibility exists that the semi-automatic focus switch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego
The Issue: The possibility exists that the semi-automatic focus switch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Artis
The Issue: The possibility exists that the semi-automatic focus switch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.