BEUDAMED
    FDA Recall Open, Classified

    Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A

    Recall: Z-1485-2026 · Initiated January 15, 2026

    Recall

    Recall Number
    Z-1485-2026
    Event Number
    98301
    Firm
    Aesculap Inc
    FEI Number
    2916714
    Product Code
    GWG
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 15, 2026
    Posted
    March 2, 2026
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    Description

    Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A

    Reason

    There is the potential for the length of the trocar shaft to be too long.

    Action

    on January 28, 2026 URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letters were sent to customers. Actions to be taken: - Review the attachment Aesculap AG Urgent Field Safety Notice in its entirety. - If it is determined that a portion of the visual field is obscured, the manufacturer recommends rotating the device to compensate for the restricted view (refer to the attached Urgent Field Safety Notice from the manufacturer). Note: Devices are not being removed from the market, this is a field notification. - Return the completed Urgent Medical Device Correction Acknowledgement Form to Aesculap, Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to [email protected] within two (2) weeks of receipt. Action planned by Aesculap AG to correct the problem: To address this issue, the manufacturer is implementing additional inspections of the optical system and introducing clearly defined acceptance criteria, along with other corrective actions. Should there be any questions, comments, or concerns regarding the product you have received, please feel free to contact (844-903-6417) or [email protected]

    Distribution

    US Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA, HI, IA, ID, IL, KS, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TX, UT, WA.

    Quantity

    126 units