BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

    Recall: Z-0886-2026 · Reported December 17, 2025

    Enforcement

    Recall Number
    Z-0886-2026
    Event ID
    97968
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 17, 2025
    Initiation Date
    October 27, 2025
    Classification Date
    December 5, 2025
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C

    Reason

    Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.

    Code Info

    UDI/DI 10193489621532 (each) 40193489621533 (case), Lot Number 25FMJ081

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    15 units