BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.

    Recall: Z-2030-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-2030-2026
    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. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585B; 2. MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585C; 3, MICRODISECTOMY PACK, Medline Kit Number/SKU DYNJ80585D.

    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 DYNJ80585B: UDI/DI each 10195327211158, UDI/DI case 40195327211159, Lot Number: 22GBV101; Medline Kit Number/SKU DYNJ80585B: UDI/DI each 10195327211158, UDI/DI case 40195327211159, Lot Number: 24IBG473; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25EBT656; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25DBN421; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25CBN640; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25BBL172; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25BBD651; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 25ABA455; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 24KBO858; Medline Kit Number/SKU DYNJ80585C: UDI/DI each 10198459154751, UDI/DI case 40198459154752, Lot Number: 24JBH693; Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Number: 26ABH754; Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Number: 25LBA242; Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Number: 25HBT362; Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Number: 25GBL430; Medline Kit Number/SKU DYNJ80585D: UDI/DI each 10198459389337, UDI/DI case 40198459389338, Lot Number: 25FBT402.

    Distribution

    Worldwide distribution.

    Quantity

    924 kits