BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B

    Recall: Z-2012-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-2012-2026
    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: SPINE PACK-LF, Medline Kit Number/SKU PHS719414B

    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

    UDI/DI each 10889942214112, UDI/DI case 40889942214113, Lot Numbers: 22GBF198, 22DBU132, 22ABJ303, 21GBV167, 21GBV186, 21BBL371.

    Distribution

    Worldwide distribution.

    Quantity

    104 kits