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 6761–6780 of 38,428 recalls
Recalled Item: Abiomed Kit
The Issue: Hole(s) to the outer pouch of the Introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abiomed Oscor Introducer Kit
The Issue: Hole(s) to the outer pouch of the Introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abiomed Kit
The Issue: Hole(s) to the outer pouch of the Introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIM TriVantage EMG Endotracheal Tubes
The Issue: Firm received reports of customers experiencing noise from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oscor Introducer Kit
The Issue: Hole(s) to the outer pouch of the Introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abiomed Kit
The Issue: Hole(s) to the outer pouch of the Introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abiomed Introducer Kit
The Issue: Hole(s) to the outer pouch of the Introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abiomed KIT
The Issue: Hole(s) to the outer pouch of the Introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The System is designed as a modular system with components
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Navik 3D v2
The Issue: IFU update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The System is designed as a modular system with components
The Issue: GE HealthCare has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier)
The Issue: Potentially defective utility trays in the reagent kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curaplex Cricothyrotomy Field Kit with Instruments
The Issue: It was determined that the Endotracheal Tube Holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curaplex Field Cric Kit with ET Tube
The Issue: It was determined that the Endotracheal Tube Holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A
The Issue: Reports of a pink or green coloration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Maestro Microcatheter
The Issue: The sterility of microcatheter and infusion system devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Pursue Microcatheter
The Issue: The sterility of microcatheter and infusion system devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fountain
The Issue: The sterility of microcatheter and infusion system devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with
The Issue: A decrease in the reactivity of HSV Type
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator
The Issue: AC Power Adapter (ACPA) may not charge the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.