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 9981–10000 of 38,428 recalls
Recalled Item: Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum
The Issue: Incorrect information on the Fungitell STAT clamshells containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConvaTec Active Life
The Issue: impaired functionality of the release liner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConvaTec Esteem+ Durahesive Plus
The Issue: impaired functionality of the release liner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConvaTec Esteem+ Durahesive Plus
The Issue: impaired functionality of the release liner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConvaTec Active Life
The Issue: impaired functionality of the release liner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fixed Core Wire Guide (Safe-T-J Curved)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heavy Double Flexible Tipped Wire Guide
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vinyl Connecting Tube
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Newton Wire Guide (LT Taper/10cm Distal Flexibility)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner PC Wire Guide (The Firm LT)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rosen Curved Wire Guide
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amplatz extra Stiff Wire Guide
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fixed Core Wire Guide
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Double Flexible Tipped Wire Guide
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cope Mandril Wire Guide (Stainless Steel)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Torq-Flex Wire Guide Australian Modification
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner PC Hydrophilic Wire Guide
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roadrunner PC Wire Guide (The Firm)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bentson Wire Guide (20cm Distal Flexibility with Softened Tip)
The Issue: Cook Medical identified that devices from the affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.