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 13641–13660 of 38,428 recalls
Recalled Item: LIAISON 1-84 PTH Assay - Product Usage: is an in
The Issue: for system to produce falsely elevated parathyroid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: uPath software 1.1 and uPath software 1.1 IVD-INSW
The Issue: When a user creates a measurement tool annotation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Acid concentrate bottles
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Acid concentrate bottles
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Acid concentrate bottles
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Citrasate Liquid Acid concentrate bottles
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Acid concentrate drums
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Acid concentrate bottles
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Citrasate Liquid Acid concentrate drums
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Acid concentrate bottles
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Acid concentrate bottles
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Acid concentrate drums
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Acid concentrate bottles
The Issue: The deviation in conductivity for sodium level exceeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien TA Auto Suture Vascular Loading Unit with DST Series
The Issue: May contain a damaged internal component which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien TA Auto Suture Vascular Stapler with DST Series Technology
The Issue: May contain a damaged internal component which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas pro integrated solutions -cobas c 503
The Issue: During the subsequent pipetting (1st or 2nd measurement),
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution CT ES - Product Usage: intended for head
The Issue: A potential for protocol(s) with unintended patient orientation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: APEX Compounding System Control Panel Module
The Issue: There is the potential for the compounding system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution CT with Apex Edition CT System - Product Usage: intended for head
The Issue: A potential for protocol(s) with unintended patient orientation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in
The Issue: Gamma-Glutamyl Transferase (GGT) Reagent Low End Repeatability-Imprecision. Reag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.