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 6421–6440 of 38,428 recalls
Recalled Item: VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate
The Issue: Tubes have missing additive/anticoagulant resulting in clotting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TECNIS Toric II OptiBlue IOL Models ZCW
The Issue: Due to intraocular lens containing an angle out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrainFeedback Pro 2 Device - is intended as an instrument
The Issue: Neurofeedback systems removed due to missing design and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM
The Issue: The expiration date is missing from the primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow-c Anesthesia System
The Issue: cybersecurity vulnerability that could lead to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Globus Medical Cranial Drill
The Issue: Sterile-packed Cranial Drills may not be sterile due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow-i C20 Anesthesia System
The Issue: cybersecurity vulnerability that could lead to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Globus Medical Cranial Drill with Stop
The Issue: Sterile-packed Cranial Drills may not be sterile due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow-e Anesthesia System
The Issue: cybersecurity vulnerability that could lead to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Globus Medical Cranial Drill with Stop
The Issue: Sterile-packed Cranial Drills may not be sterile due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow-i C30 Anesthesia System
The Issue: cybersecurity vulnerability that could lead to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow-i C40 Anesthesia System
The Issue: cybersecurity vulnerability that could lead to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST)
The Issue: There is the potential for incomplete staple line
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WAVi Research EEG Desktop System is comprised of the WAVi
The Issue: Following an FDA-issued Warning Letter, the firm requested
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III
The Issue: Single Use Distal Cover MAJ-2315 may unexpectedly detach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet
The Issue: Loss of connectivity between the FlexArm and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet
The Issue: Loss of connectivity between the FlexArm and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XScribe CP Cardiac Stress Testing System
The Issue: distortion identified in electrocardiogram (ECG) readings when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Q-Stress Cardiac Stress Testing System
The Issue: distortion identified in electrocardiogram (ECG) readings when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XScribe Cardiac Stress Testing System
The Issue: distortion identified in electrocardiogram (ECG) readings when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.