BEUDAMED
    FDA Recall Open, Classified

    Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235

    Recall: Z-2277-2025 · Initiated July 2, 2025

    Recall

    Recall Number
    Z-2277-2025
    Event Number
    97133
    Firm
    Stryker Corporation
    FEI Number
    3015967359
    Product Code
    KCY
    Status
    Open, Classified
    Root Cause
    Equipment maintenance
    Initiated
    July 2, 2025
    Posted
    August 7, 2025
    Address
    1941 Stryker Way, Portage, MI, 49002-9711

    Description

    Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235

    Reason

    Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.

    Action

    On July 2, 2025, the firm notified customers via Urgent Medical Device Recall letters. Customers were instructed to locate and quarantine any affected products at their facility and return an enclosed business reply form to the firm. Stryker will provide a shipping label to return the affected product, and credit will be issued to affected customers upon receipt of the recalled product.

    Distribution

    Domestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom

    Quantity

    233.230