BEUDAMED
    FDA Enforcement Class II Ongoing

    ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

    Recall: Z-2063-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2063-2026
    Event ID
    98674
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Erbe Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 13, 2026
    Initiation Date
    March 31, 2026
    Classification Date
    May 1, 2026
    Address
    405 W Geneva Dr, Tempe, AZ, 85282-2003, United States

    Description

    ERBEFLO CleverCap: Hybrid Tubing/Cap Set for Olympus Scopes, 20325-201; ERBEFLO CleverCap Hybrid Tubing/Cap Set for Fujifilm Scopes, REF: 20325-203;

    Reason

    Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.

    Code Info

    REF/UDI-DI/Lots: 20325-201/04065655000603/W4466253, W4466254, W4466256, W4466257, W4466258, WO471080, WO471081, WO471083, WO471084, WO473975, WO473976, WO477586, WO477587, WO477588, WO477589, WO477590; 20325-203/04065655001211/WO473986

    Distribution

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

    Quantity

    23,359