BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A

    Recall: Z-2009-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-2009-2026
    Event ID
    98664
    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
    May 6, 2026
    Initiation Date
    March 19, 2026
    Classification Date
    April 30, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A

    Reason

    During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

    Code Info

    Medline Kit Number SKU DYNJ86657A: UDI/DI each 10198459431678, UDI/DI case 40198459431679, Lot Numbers: 26ABM977, 25KBM387, 25IBG995, 25GBW704.

    Distribution

    Worldwide distribution.

    Quantity

    306 kits