BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.

    Recall: Z-0523-2026 · Reported November 26, 2025

    Enforcement

    Recall Number
    Z-0523-2026
    Event ID
    97846
    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
    September 30, 2025
    Classification Date
    November 14, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.

    Reason

    Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.

    Code Info

    1) REF DYNJ0161768G: UDI/DI 10195327404567 (each) 40195327404568 (case), Lot Numbers: 23FDA201, 23HDB248; 2) REF DYNJ67757B: UDI/DI 10195327228002 (each) 40195327228003 (case), Lot Numbers: 23EBK325, 23HBM888, 23IBP459, 23JBV413.

    Distribution

    US Nationwide distribution.

    Quantity

    424 kits