BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7

    Recall: Z-1431-2026 · Reported March 4, 2026

    Enforcement

    Recall Number
    Z-1431-2026
    Event ID
    98319
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 4, 2026
    Initiation Date
    January 5, 2026
    Classification Date
    February 20, 2026
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7

    Reason

    Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.

    Code Info

    MDSALINE7 - UDI-DI: 10193489089356 (each), 20193489089353 (case), All Lots

    Distribution

    Worldwide distribution - US Nationwide and the countries of Bahamas, Bermuda, Cayman Islands.

    Quantity

    3,578,805 units