BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated October 6, 2025

    Recall

    Recall Number
    Z-0482-2026
    Event Number
    97733
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FDI
    Status
    Open, Classified
    Root Cause
    Packaging
    Initiated
    October 6, 2025
    Posted
    November 7, 2025
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    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.

    Action

    On October 6, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: Examine your inventory and quarantine any affected devices. Cease usage of the product immediately. Please contact customer service to request a return material authorization, a credit will be issued for any returned product. Please forward this notice to other users who may have the affected products if you have further distributed it. Olympus requests you to report any complaints, including holes in device packaging, to our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail [email protected].

    Distribution

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

    Quantity

    48208 units