BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.

    Recall: Z-2018-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-2018-2026
    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. OSC COLEMAN FAT HARVEST KIT, Medline Kit Number/SKU DYNJ32854B; 2. RR-DR. CHHETRI MDL PACK, Medline Kit Number/SKU DYNJ62635B.

    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 DYNJ32854B: UDI/DI each 10198459413414, UDI/DI case 40198459413415, Lot Number : 25GBU656; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25GMD214; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25FMC376; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25DMJ030; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25BME902; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 25AMJ032; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 24IMH612; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 24EME486; Medline Kit Number/SKU DYNJ62635B: UDI/DI each 10195327634780, UDI/DI case 40195327634781, Lot Number : 24DMD315; Medline Kit Number/SKU DYNJ62635C: UDI/DI each 10198459485619, UDI/DI case 40198459485610, Lot Number : 26BMD607; Medline Kit Number/SKU DYNJ62635C: UDI/DI each 10198459485619, UDI/DI case 40198459485610, Lot Number : 25JMD196.

    Distribution

    Worldwide distribution.

    Quantity

    208 kits