Color Cuff - Sterile Disposable Tourniquet Cuffs

There is potential for the tourniquet cuffs flange to detach from the bladder where the welding connection is, which may result in the cuff not able to maintain air pressure. On February 12, 2025, a nonconformance was opened to address a manufacturing nonconformance identified through a Stryker complaint investigation for the tourniquet cuff flange becoming detached from the bladder. Less noticeable detached flanges have been reported and events confirmed.

Recall start date: June 27, 2025