BEUDAMED
    FDA Enforcement Class II Ongoing

    Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

    Recall: Z-0363-2025 · Reported November 20, 2024

    Enforcement

    Recall Number
    Z-0363-2025
    Event ID
    95607
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Karl Storz Endoscopy
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2024
    Initiation Date
    October 21, 2024
    Classification Date
    November 12, 2024
    Address
    2151 E Grand Ave, N/A, El Segundo, CA, 90245-5017, United States

    Description

    Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

    Reason

    Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

    Code Info

    Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222

    Distribution

    U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.

    Quantity

    40 units