10 Biggest Medical Device Recalls of 2016—Cook Medical Beacon Tip

Device: Torcon NB Advantage Beacon Tip Catheters, Royal Flush Plus Beacon Tip High-Flow Catheters, Slip-Cath Beacon Tip Hydrophilic Catheters, Shuttle Select Slip-Cath Catheters. Click here for information on specific catalog and lot numbers.

Recall reason: According to information on the FDA recall page, there were "complaints that the catheter tip may split or separate and could potentially enter the patient's blood stream." This could lead to serious injury or even death, and the device may not work.

When recall was initiated: Initiated July 2015 and expanded February 25, 2016

Number of U.S. units impacted: 408,011 units

For more information, visit the FDA Recall page.