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 29361–29380 of 38,428 recalls
Recalled Item: Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿...
The Issue: Multi-Function Defibrillation Electrodes, Pre connect- potential for damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item...
The Issue: Multi-Function Defibrillation Electrodes, Pre connect- potential for damage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Actifuse ABX/Actifuse MIS System A bone void filler intended only
The Issue: Baxter Healthcare is issuing a voluntary recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Force
The Issue: Software and firmware bugs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Marker Spheres The Disposable Marker Spheres used
The Issue: Disposable Reflective Marker Spheres (DRMS) for Brainlab Image
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microtek Medical
The Issue: The sterile packaging may contain small (less than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PenBlade Safety Scalpel
The Issue: Cracks were discovered in the PET tray of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid
The Issue: Some devices exhibit backup VVI operation due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTRONIC PERFUSION TUBING PACKS (with potentially affected...
The Issue: Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration perfo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDIVATORS HEMOCOR HPH700
The Issue: Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration perfo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge Group
The Issue: Two serious thromboembolic events were reported involving the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Getinge Group
The Issue: Two serious thromboembolic events were reported involving the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIOS ALPHA
The Issue: patient procedure interruption due to a potential system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi Surgical System P4 software
The Issue: Complaints regarding the Exposed Knife Blade recoverable fault
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFX-8000V Bi-Plane X-Ray Interventional System X-ray systems
The Issue: When a fontal DA (Digital Angiography) acquisition was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Flash
The Issue: software bug issues for SW-Version VA48A_SP0. The following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Edge
The Issue: software bug issues for SW-Version VA48A_SP0. The following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS
The Issue: software bug issues for SW-Version VA48A_SP0. The following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor
The Issue: The dimensions of the mating features of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm
The Issue: The dimensions of the mating features of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.