BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.

    Recall: Z-0482-2026 · Reported November 19, 2025

    Enforcement

    Recall Number
    Z-0482-2026
    Event ID
    97733
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 19, 2025
    Initiation Date
    October 6, 2025
    Classification Date
    November 7, 2025
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States

    Description

    Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.

    Reason

    Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.

    Code Info

    Model: SD-400U-10; Lot Numbers: 27V, 28V, 29V, 2XV, 2YV, 2ZV, 31V, 32V, 33V, 34V, 35V, 36V, 37V, 38V, 39V, 3XV, 3YV, 3ZV, 41V, 42V, 43V, 44V, 45V, 46V, 47V, 48V, 49V, 4XV, 4YV, 51V, 52V, 53V, 54V, 55V, 56V, 57V UDI: 04953170408243

    Distribution

    Worldwide distribution - US Nationwide and the countries of GU, and MP.

    Quantity

    48208 units