BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A

    Recall: Z-0309-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0309-2026
    Event ID
    97649
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesculap Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2025
    Initiation Date
    September 24, 2025
    Classification Date
    October 24, 2025
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A

    Reason

    It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

    Code Info

    Model No EK083P; UDI-DI: 04046963417710; Lots 52978946, 52991996, 53002275, 53004669, 53006807, 52941286, 52956527, 52956740, 52956952, 52957393, 52967167

    Distribution

    Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD, NE, NM, NY, OR, PA, WA, WI and the country of Canada.

    Quantity

    26 units