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 21201–21220 of 38,428 recalls
Recalled Item: LINX Management System
The Issue: out of specification condition which may allow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINX Management System
The Issue: out of specification condition which may allow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINX Management System
The Issue: out of specification condition which may allow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINX Management System
The Issue: out of specification condition which may allow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Stockert Heater-Cooler System 3T
The Issue: Firm is notifying customers that the Deep-Cleaning Service
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Gentamicin Flex reagent cartridge
The Issue: The affected lots may exhibit inaccuracy for Quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Gentamicin Flex reagent cartridge
The Issue: The affected lots may exhibit inaccuracy for Quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroAire SmartRelease Endoscopic System
The Issue: The Instructions for Use (IFU) is incorrect with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VOLISTA StandOP (model 600) surgical lights shipped from October 2012
The Issue: keypad failure on VOLISTA StandOP Surgical Lights
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD)
The Issue: It was found when an operator performs a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BLAST Bandage
The Issue: Blast Bandages (part# BLAST) with Lot# 0617 were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amalgatome SD
The Issue: Improper installation of hand piece may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators
The Issue: There is a potential for the cord to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ulnar Osteotomy Compression Plate
The Issue: Two instrument holes located on the side of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor
The Issue: The firm is advising physicians that exposure to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model
The Issue: The firm is advising physicians that exposure to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin PCS programmer (Model # 3650)
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unify
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fortify
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fortify Assura
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.