Official recall record
Color Cuff - Sterile Disposable Tourniquet Cuffs
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-07-09
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.