Stryker Tourniquet Cuff Pressure Failure May Cause Bleeding
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs may fail to achieve or maintain desired pressure during surgical setup, potentially causing operative site bleeding or hemorrhage.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for serious surgical complications including hemorrhage. No illnesses or injuries have been reported in the source; the hazard is based on the documented defect mechanism and theoretical harm.
Plain-English summary
Stryker Corporation is recalling specific lots of Color Cuff Non-Sterile Disposable Tourniquet Cuffs due to a pressure failure defect. The affected product is catalog number 5921-218-235NS, distributed nationwide.
The recalled cuffs may not achieve the desired pressure or may fail to hold pressure during initial cuff setup on the patient. This defect can result in operative site blood loss, hemorrhage, or in rare cases, other serious surgical complications. A total of 1,707 units have been distributed.
Affected lot numbers are: 2022111802, 2022112904, 2022121301, 2022121302, 2022121905, 2022121906, 2022121907, 2022121908. Healthcare facilities should identify and quarantine affected inventory and verify proper pressure maintenance during setup procedures before patient use.
The recalled product
- Product
- Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities
- Manufacturer
- Stryker Corporation
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Stryker Corporation
See all →- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighStryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
Same hazard · pressure failure
See all →- SevereDrinkmate one litre carbonation bottles can explode during use
CPSC · 2025-08-14
- Severe
- HighCleaner Bottles May Disassemble Under Pressure During Treatment
FDA (Devices) · 2024-05-01
- HighStryker Tourniquet Cuff Pressure Failure May Lead to Blood Loss
FDA (Devices) · 2023-04-12
- HighStryker Tourniquet Cuff Pressure Failure May Cause Hemorrhage During Surgery
FDA (Devices) · 2023-04-12