BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2136-2025 · Initiated June 11, 2025

    Recall

    Recall Number
    Z-2136-2025
    Event Number
    97028
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    HIB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 11, 2025
    Posted
    July 18, 2025
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    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.

    Action

    CooperSurgical notified consignees on about 06/11/2025 via letter sent through certified mail. Specifically, consignees that are physicians or medical facilities were instructed to identify and quarantine any affected product in inventory, complete and return the provided response form, and work with CooperSurgical to arrange for the return of affected units. Distributors were instructed to identify and quarantine any affected product in inventory, complete and return the provided response form, and work with CooperSurgical to arrange for the return of affected units. They were also instructed to notify customers if the product was further distributed.

    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