BEUDAMED
    FDA Recall Open, Classified

    Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A

    Recall: Z-0311-2026 · Initiated September 24, 2025

    Recall

    Recall Number
    Z-0311-2026
    Event Number
    97649
    Firm
    Aesculap Inc
    FEI Number
    2916714
    Product Code
    GCJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 24, 2025
    Posted
    October 24, 2025
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A

    Reason

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

    Action

    On September 24, 2025 URGENT MEDICAL DEVICE RECALL NOTIFICATION letters were sent to customers. Actions to be taken. 1. Review the recall notice and ensure all users in the organization are notified. Forward this notification to customers. Remove affected units from inventory, quarantine the product but do not destroy it. Complete and return the included response form. Return affected units to the firm. Credit of the product will be issued. An alternative disposable universal seal is available and can be ordered.

    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