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 6741–6760 of 38,428 recalls
Recalled Item: DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated
The Issue: Due to incorrect product/device within packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet PowerLED/HLED and PowerLED300 OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Blueline Series 30/80 OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Rolite OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Lucea - Lucea10/40
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet PowerLEDII OR Light System
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Equipment OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Volista
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Hanaulux HLX3000 OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet G8 / G8E OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Axcel / Axcel + OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Hanaulux HLX2000 OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Hanaulux 2006/ 2007
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet XTen OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Prismalix OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Orchide OR Light Systems
The Issue: A potential for a light system to fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission
The Issue: The internal diameter of the coaxial cannula may
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: Oscor Intro 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 Axillary Insertion Introducer -Introducer(s) are intended for...
The Issue: Hole(s) to the outer pouch of the Introducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.