BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.

    Recall: Z-2023-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-2023-2026
    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: 1. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ58648J; 2. ENT ENDO SINUS WILMINGTON PACK, Medline Kit Number/SKU DYNJ66447; 3. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362B.

    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 DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23JMD938; Medline Kit Number/SKU DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23HMG766; Medline Kit Number/SKU DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 23DMD129; Medline Kit Number/SKU DYNJ58648J: UDI/DI each 10195327212124, UDI/DI case 40195327212125, Lot Number: 22KMD675; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23JBM687; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23EBD581; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23DBH247; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23CBS705; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23BBF189; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22JBF016; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22HBR972; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22DBO928; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 22DBO407; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 24ABP390; Medline Kit Number/SKU DYNJ66447: UDI/DI each 10193489356793, UDI/DI case 40193489356794, Lot Number: 23LBN206; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23KLA222; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23JLA551; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23ILA611; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23HLA926; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23FLA515; Medline Kit Number/SKU DYNJ908362B: UDI/DI each 10195327404468, UDI/DI case 40195327404469, Lot Number: 23LLA801.

    Distribution

    Worldwide distribution.

    Quantity

    1824 kits