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 23261–23280 of 38,428 recalls
Recalled Item: Cell Marque
The Issue: A delay in transit may have contributed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Marque
The Issue: A delay in transit may have contributed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Marque
The Issue: A delay in transit may have contributed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Marque
The Issue: A delay in transit may have contributed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Marque
The Issue: A delay in transit may have contributed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Marque
The Issue: A delay in transit may have contributed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Marque
The Issue: A delay in transit may have contributed to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Video Cystoscope models ECY-1570 and ECY-1570K
The Issue: The video cytoscopes lack 510(k) premarket notification clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ReNew Reusable Grasper and Dissector Tips are to be
The Issue: The heat-shrink insulation tube may split during autoclave
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE
The Issue: Device does not produce a visual or audible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THERMI250 Radiofrequency System. Intended to provide heating for the purpose
The Issue: In some systems, the unit continues to emit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is
The Issue: for intermittent lighting (flickering) during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solarice Rapid Exchange Balloon Dilatation Catheter
The Issue: Stylette removal difficulties on the Euphora and Solarice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Euphora Rapid Exchange Balloon Dilatation Catheter
The Issue: Stylette removal difficulties on the Euphora and Solarice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm
The Issue: The firm received several customer complaints reporting some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORAIL HIGH OFFSET STEM Collarless SIZE 14
The Issue: Incorrect device in the package. A package that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9
The Issue: Incorrect device in the package. A package that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRx Defibrillator Model # M3535A & M3536A
The Issue: Affected units may have a defective component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK¿ 2 Compact 30
The Issue: Customers have reported that some VITEK¿ 2 cards
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK¿ 2 Compact 15
The Issue: Customers have reported that some VITEK¿ 2 cards
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.