BEUDAMED
    FDA Enforcement Class I Ongoing

    Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.

    Recall: Z-0570-2026 · Reported December 3, 2025

    Enforcement

    Recall Number
    Z-0570-2026
    Event ID
    97731
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2025
    Initiation Date
    October 30, 2025
    Classification Date
    November 25, 2025
    Address
    3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States

    Description

    Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.

    Reason

    Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

    Code Info

    Model/Catalog Number: HX-400U-30; UDI: 04953170368615; All Lots which have not expired;

    Distribution

    US-wide distribution

    Quantity

    7803 units