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 16261–16280 of 38,428 recalls
Recalled Item: Medical convenience trays and kits
The Issue: The kits contain a bottle of saline solution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate 3 Mobile Power Unit
The Issue: Excessive static electricity can potentially cause unrecoverable power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invia Foam Dressing Kit with FitPad - X-Large (3 pcs)
The Issue: Invia Foam Dressing Kit with FitPad could have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: aap Implantate AG
The Issue: The company has become aware that the soft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3
The Issue: The firm has received reports that the spring/washer/bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BriteBlade Pro Single-se Fiber Optic Miller 2
The Issue: The firm has received reports that the spring/washer/bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2
The Issue: The firm has received reports that the spring/washer/bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuickDraw Venous Cannula
The Issue: If the venous cannula is used in an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BriteBlade Pro Single-Use Fiber Optic Mac 3
The Issue: The firm has received reports that the spring/washer/bearing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iMRX MRI and Angiography System
The Issue: There is a potential hardware error for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bellavista 1000 ventilator
The Issue: The G6 bellavista 1000 US ventilators may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VACUETTE TUBE
The Issue: The Vacuette 3.5mL Serup Sep Clot Activator Tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to
The Issue: GE Healthcare has become aware that there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to
The Issue: GE Healthcare has become aware that there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios Alpha
The Issue: During a routine inspection of a system, a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo AZUR CX Peripheral Coil System
The Issue: The devices may be missing the implant coil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo AZUR Peripheral Coil System
The Issue: The devices may be missing the implant coil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo AZUR Peripheral Coil System
The Issue: The devices may be missing the implant coil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo AZUR Peripheral Coil System
The Issue: The devices may be missing the implant coil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo AZUR CX Peripheral Coil System
The Issue: The devices may be missing the implant coil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.