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 16721–16740 of 38,428 recalls
Recalled Item: LAG SCREW 3.2MM GUIDE PIN SLEEVE
The Issue: LAG SCREW 3.2 GUIDE PIN SLEEVE are being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System
The Issue: The firm became aware of a cleaning solution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that IV administration sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that IV administration sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that IV administration sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that IV administration sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 111" 10 Drop Admin Set w/2 Inj Sites
The Issue: There is a potential that IV administration sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that IV administration sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that IV administration sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that IV administration sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that IV administration sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: There is a potential that IV administration sets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche Homocysteine-In vitro test for the quantitative determination of total
The Issue: Homocysteine Reagent, Calibration Failures and Quality Control Recovery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Liquid Cardiac Controls Catalogue Numbers CQ5053.
The Issue: Removal of claims for N-proBNP in the Liquid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WECK Hem-O-Lok AutoEndo5
The Issue: Certain clip appliers have an increase in misloading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WECK AutoEndo5
The Issue: Certain clip appliers have an increase in misloading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Liquid Cardiac Controls Catalogue Number CQ5051
The Issue: Removal of claims for N-proBNP in the Liquid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox Liquid Cardiac Controls Catalogue Number CQ5052.
The Issue: Removal of claims for N-proBNP in the Liquid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neocis Guidance System Fiducial Array - Product Usage: The Neocis
The Issue: The Fiducial Array may mismatch their measurement files
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex Control Unit
The Issue: Communication error alarms may result in interruption of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.