BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.

    Recall: Z-2035-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-2035-2026
    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. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269B; 2. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269C; 3. ROBOTIC HYSTERECTOMY, Medline Kit Number/SKU DYNJ904269D.

    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 DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21KBM212; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21IBT678; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21GBF973; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21EBR775; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21DBH715; Medline Kit Number/SKU DYNJ904269B: UDI/DI each 10193489251630, UDI/DI case 40193489251631, Lot Number: 21BBI962; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22HBO534; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22FBY086; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22FBG752; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22CBY116; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 22ABS155; Medline Kit Number/SKU DYNJ904269C: UDI/DI each 10195327040079, UDI/DI case 40195327040070, Lot Number: 21LBF114; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23JBN926; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23FBE547; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23EBI633; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23DBA946; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23CBD209; Medline Kit Number/SKU DYNJ904269D: UDI/DI each 10195327275938, UDI/DI case 40195327275939, Lot Number: 23ABH377.

    Distribution

    Worldwide distribution.

    Quantity

    632 kits