BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A

    Recall: Z-0312-2026 · Reported November 5, 2025

    Enforcement

    Recall Number
    Z-0312-2026
    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: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A

    Reason

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

    Code Info

    Model No EK087P; UDI-DI: 04046963620059; Lots 52974276, 52952133, 52954633, 52959357, 52964442, 52968887, 52972214, 52977427, 52981208, 52985519, 52988828, 52992514, 52993617, 52997919, 53002094, 53004347, 53006380, 53007625, 53010869, 53013557

    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

    155 units