BEUDAMED
    FDA Enforcement Class II Ongoing

    Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt Tonsil Forceps SLT-CVD185MM; (4) REF BH959R, Schnidt Tonsil Forceps CVD 185MM; (5) REF BH961R, Schnidt Tonsil FCPSOPEN-RINGCVD 185MM; (6) REF BH963R, Schnidt Tonsil FCPSOPEN-RINGCVD185MM; and (7) REF BH965R, Wilson Tonsil Forceps 190MM.

    Recall: Z-1312-2025 · Reported March 19, 2025

    Enforcement

    Recall Number
    Z-1312-2025
    Event ID
    96223
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesculap Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 19, 2025
    Initiation Date
    January 31, 2025
    Classification Date
    March 11, 2025
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, Negus Tonsil Forceps HVY-CVD 190MM; (2) REF BH952R, Negus Tonsil Forceps X-HVY-CVD190MM; (3) REF BH957R, Schnidt Tonsil Forceps SLT-CVD185MM; (4) REF BH959R, Schnidt Tonsil Forceps CVD 185MM; (5) REF BH961R, Schnidt Tonsil FCPSOPEN-RINGCVD 185MM; (6) REF BH963R, Schnidt Tonsil FCPSOPEN-RINGCVD185MM; and (7) REF BH965R, Wilson Tonsil Forceps 190MM.

    Reason

    The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

    Code Info

    GTIN numbers: (1) REF BH951R - 04038653027026; (2) REF BH952R - 04038653139200; (3) REF BH957R - 04038653027033; (4) REF BH959R - 04038653027040; (5) REF BH961R - 04038653027057; (6) REF BH963R - 04038653027064; and (7) REF BH965R - 04038653027071.

    Distribution

    Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.

    Quantity

    47,078 forceps