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 12661–12680 of 38,428 recalls
Recalled Item: Angio Pack
The Issue: Angio tubing included within Custom Convenience kits may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Angio Pack
The Issue: Angio tubing included within Custom Convenience kits may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse...
The Issue: Emergency Use Application (EUA) application withdrawn as false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs
The Issue: Emergency Use Application (EUA) application withdrawn as false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage:
The Issue: Recall reason is possible sporadic false negative conventional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation standalone software radiation therapy treatment planning system....
The Issue: When using more than one plan in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.