BEUDAMED
    FDA Enforcement Class II Ongoing

    Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

    Recall: Z-2136-2025 · Reported July 30, 2025

    Enforcement

    Recall Number
    Z-2136-2025
    Event ID
    97028
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 30, 2025
    Initiation Date
    June 11, 2025
    Classification Date
    July 18, 2025
    Address
    95 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit

    Reason

    The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

    Code Info

    Model Number: ES-TRAY. UDI-DI: 60888937027268. Lot Numbers: 335995, 339340, 339341, 339342, 339343, 339344, 339345, 343008.

    Distribution

    US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington DC.

    Quantity

    991 units