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 37701–37720 of 38,428 recalls
Recalled Item: PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips
The Issue: During a routine product investigation, a creatinine sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Triage Tox+MTD Drug Screen
The Issue: A recall was initiated because Alere San Diego
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hartmann Econolux 105 Sterile Gauze sponge 4"x4" 12-ply
The Issue: Micro holes were detected in the laminate of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hartmann Sterilux Sterile Premium gauze sponge 4"x4" 12-ply
The Issue: Micro holes were detected in the laminate of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BriteField illuminated Suction Device
The Issue: Invuity is notifying customers to return all obsolete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid...
The Issue: Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C
The Issue: In some cases, the system is unable to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P....
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7....
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J....
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P....
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7....
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J....
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J....
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P....
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P....
The Issue: The device is being recalled because the firm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Churchill Medical Systems
The Issue: Manufacturer issued a voluntary recall on multiple lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system
The Issue: If a lead ruler is not positioned in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.