Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Color Cuff Single Port Recalled by Stryker Sustainability Solutions Due to Increased incidence of disposable tourniquet cuffs "not able...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Sustainability Solutions directly.
Affected Products
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235; Color Cuff Single Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235;
Quantity: 127,894
Why Was This Recalled?
Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Sustainability Solutions
Stryker Sustainability Solutions has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report