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 8521–8540 of 38,428 recalls
Recalled Item: Sterile surgical convenience kit: regard Item Number: 880393003
The Issue: The recalling firm was notified by their supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaOne Reusable Positioning Cannula 11mm Standard
The Issue: There is a manufacturing non-conformance that may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile surgical convenience kits: 1. regard Item Number: 880353009
The Issue: The recalling firm was notified by their supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile surgical convenience kits: 1. regard Item Number: 880473001
The Issue: The recalling firm was notified by their supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile surgical convenience kits: 1. regard Item Number: 800756005
The Issue: The recalling firm was notified by their supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile surgical convenience kits: 1. regard Item Number: 880405003
The Issue: The recalling firm was notified by their supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile surgical convenience kit: regard Item Number: 800718003
The Issue: The recalling firm was notified by their supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaOne Reusable Positioning Cannula 12mm Standard
The Issue: There is a manufacturing non-conformance that may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaOne Reusable Positioning Cannula 8 mm Standard
The Issue: There is a manufacturing non-conformance that may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Kiestra InoqulA+ with BD Kiestra" InoqulA+" and BeA Software
The Issue: Upon installation of BD Kiestra" InoqulA+" and BeA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion System with software versions: R2.2.O
The Issue: Loss of X-ray-When the full disk capacity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBRA-OS
The Issue: Custom sheath Introducer contains incorrect needle size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and...
The Issue: for the spring to become loose and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X
The Issue: Additional Label Warnings: Amendment / reinforcement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP
The Issue: Additional Label Warnings: Amendment / reinforcement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X
The Issue: Additional Label Warnings: Amendment / reinforcement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP
The Issue: Additional Label Warnings: Amendment / reinforcement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP
The Issue: Additional Label Warnings: Amendment / reinforcement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X
The Issue: Additional Label Warnings: Amendment / reinforcement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP
The Issue: Additional Label Warnings: Amendment / reinforcement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.