BEUDAMED
    FDA Enforcement Class II Ongoing

    Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes

    Recall: Z-0234-2026 · Reported October 29, 2025

    Enforcement

    Recall Number
    Z-0234-2026
    Event ID
    97675
    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
    October 29, 2025
    Initiation Date
    September 11, 2025
    Classification Date
    October 23, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes

    Reason

    Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.

    Code Info

    UDI (Case): 10363807000039, UDI (Box): 363807000032, UDI (Each): 363807100114, Lot Numbers: 25AJA049, 25BJA001, 25BJA032, 25CJA053, 25CJA105, 25CJA158,

    Distribution

    Distribution US nationwide and Canada

    Quantity

    8,267,150 syringes