BEUDAMED
    FDA Recall Open, Classified

    AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

    Recall: Z-0026-2026 · Initiated August 18, 2025

    Recall

    Recall Number
    Z-0026-2026
    Event Number
    97507
    Firm
    Aesculap AG Am Aesculap-Platz 1 Tuttlingen Germany
    FEI Number
    3002806315
    Product Code
    HBB
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 18, 2025
    Posted
    October 2, 2025

    Description

    AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.

    Reason

    Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."

    Action

    Asculap notified consignees with an "Urgent Field Safety Notice" dated 8/18/2025 via email. Consignees were instructed to identify affected units, arrange for their return, and complete and return the response form provided with the letter. If you have any question, call 484.240.8373 or email:[email protected].

    Distribution

    US distribution to Missouri. OUS International distribution to Norway, Portugal, France, Great Britian, Czech Republic, Germany, Turkey, Brazil, Japan, Chile, China, Hong Kong, Indonesia, India, Iran, Mexico, Malaysia, Philippines, Saudi Arabia, Thailand.

    Quantity

    1 unit