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 34641–34660 of 38,428 recalls
Recalled Item: Single Site Curved Needed Driver Intuitive Surgical
The Issue: A limited number of FDA-cleared instruments for da
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Site Bipolar Maryland Forceps Intuitive Surgical
The Issue: A limited number of FDA-cleared instruments for da
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System
The Issue: Toshiba intitiated this recall because their investigation revealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product
The Issue: Oxygen and air wall inlet fittings on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System
The Issue: Oxygen and air wall inlet fittings on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare - Giraffe Warmer
The Issue: Oxygen and air wall inlet fittings on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker...
The Issue: Stryker received a report from the field indicating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated
The Issue: There is an issue associated with Digital Pathology
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
The Issue: InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine
The Issue: Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM
The Issue: Stryker has received complaints associated with cracks and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM
The Issue: Stryker has received complaints associated with cracks and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The
The Issue: A potential non conformance was identified with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic RestoreUltra
The Issue: Medtronic notified customers regarding Loss of Stimulation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended
The Issue: Cases were encountered with the Draeger Movita 603x/DVE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Activa PC
The Issue: Medtronic notified customers regarding Loss of Stimulation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adjustable Gastric Band
The Issue: During aging studies, the firm determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adjustable Gastric Band
The Issue: During aging studies, the firm determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adjustable Gastric Band
The Issue: During aging studies, the firm determined that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic RestoreUltra
The Issue: Medtronic notified customers regarding over stimulation or stimulation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.