BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0234-2026 · Initiated September 11, 2025

    Recall

    Recall Number
    Z-0234-2026
    Event Number
    97675
    FEI Number
    1417592
    Product Code
    NGT
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 11, 2025
    Posted
    October 23, 2025
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    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.

    Action

    Medline issued an Urgent Medical Device Recall notice to its consignees on 9/11/2025 via email and mail. The notice discussed the issue, potential risk, and noted that affected boxes of syringes were also inadvertently packaged within cases of syringe lots that meet all requirements and were still safe for use. Within the item number, EMZ111240, the firm specified which lots were to be destroyed and which lots were safe to use. Cases of certain lots labeled with safe to use codes must be opened and inspected for affected units which must be destroyed. A response is required to receive credit for the destroyed affected units. For questions, please contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    Distribution US nationwide and Canada

    Quantity

    8,267,150 syringes