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 2721–2740 of 38,428 recalls
Recalled Item: Proxima Drape labeled as HEAD AND NECK OSIS
The Issue: breach in pouch packaging which could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Low Profile Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
The Issue: breach in pouch packaging which could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
The Issue: breach in pouch packaging which could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW
The Issue: breach in pouch packaging which could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical ProPort Plastic Venous Access System
The Issue: The plastic port housing and port reservoir of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proxima Drape labeled as FACE LIFT. Sterile surgical drape.
The Issue: breach in pouch packaging which could lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C
The Issue: The potential for devices to fail their self-test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:
The Issue: The potential for devices to fail their self-test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:
The Issue: The potential for devices to fail their self-test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:
The Issue: The potential for devices to fail their self-test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:
The Issue: The potential for devices to fail their self-test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:
The Issue: The potential for devices to fail their self-test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Endotracheal Tube
The Issue: Affected devices have a smaller diameter than expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number:
The Issue: The potential for devices to fail their self-test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A
The Issue: The potential for devices to fail their self-test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.