Recall Z-1804-2026— Stryker Sustainability Solutions

Name: FDA recall Z-1804-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Class II · Ongoing

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2026-03-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.. Reason: Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Ongoing
Initiated: 2026-03-12
Firm location: Tempe, AZ, United States

Product description

Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.

Reason for recall

Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.

Data sourced from openFDA. This site is unofficial and independent of the FDA.