BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.

    Recall: Z-0510-2026 · Reported November 26, 2025

    Enforcement

    Recall Number
    Z-0510-2026
    Event ID
    97815
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 26, 2025
    Initiation Date
    October 3, 2025
    Classification Date
    November 14, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F.

    Reason

    Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals.

    Code Info

    1) REF: DYNJ37743D: UDI/DI 10193489600124 (each), 40193489600125 (case), Lot Number 25EMI333; 2) REF: DYNJ37743F: UDI/DI 10198459390685 (each), 40198459390686 (case), Lot Number 25GMD927.

    Distribution

    US: MO

    Quantity

    1024 units