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 37161–37180 of 38,428 recalls
Recalled Item: Anatomical Shoulder" Revision Humeral stem
The Issue: Zimmer Inc., is initiating a correction to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MS-30 Shaft
The Issue: Zimmer Inc., is initiating a correction to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Inverse/Reverse Screw system
The Issue: Zimmer Inc., is initiating a correction to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anatomical Shoulder" Ball taper for humeral stem
The Issue: Zimmer Inc., is initiating a correction to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel
The Issue: Eon Mini IPGs manufactured in April 2012 could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel¿ DxC 600/800 with Software v5.0.11
The Issue: Beckman Coulter has confirmed that the Shuttle to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Brilliance CT Big Bore is a whole-body Computed Tomography
The Issue: Philips Healthcare received a complaint stating the system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch + Lomb Stellaris PC Vision Enhancement System
The Issue: Posterior fluidics modules installed in the system may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multipolar¿ Bipolar Cup Liner 22 mm LD.
The Issue: Zimmer Inc. is initiating a removal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump
The Issue: Accuro has received reports of some Apex Pumps
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STRYKER Sustainability Solutions
The Issue: Reports that the AC Power Adaptor may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE
The Issue: Lines on the screw gauge may not placed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PREMIER(R) Anterior Cervical Plate System SCREW BLOCK
The Issue: Lines on the screw gauge may not placed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE
The Issue: Lines on the screw gauge may not placed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guardian II Hemostasis Valve
The Issue: Vascular Solutions, Inc., became aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T-Handle
The Issue: During an operation the strike plate of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbiq One Channel Infuser
The Issue: The Symbiq pump touchscreen may not respond to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbiq Two Channel Infuser
The Issue: The Symbiq pump touchscreen may not respond to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.