BEUDAMED
    FDA Enforcement Class II Ongoing

    Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

    Recall: Z-2166-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2166-2026
    Event ID
    98696
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2026
    Initiation Date
    April 9, 2026
    Classification Date
    May 12, 2026
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400, United States

    Description

    Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

    Reason

    Due to nonconforming products being inadvertently distributed.

    Code Info

    Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601

    Distribution

    U.S. Nationwide distribution in the state of GA.

    Quantity

    10 tube sets