BEUDAMED
    FDA Recall Open, Classified

    ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

    Recall: Z-1690-2026 · Initiated February 13, 2026

    Recall

    Recall Number
    Z-1690-2026
    Event Number
    98524
    FEI Number
    1417592
    Product Code
    PIO
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    February 13, 2026
    Posted
    March 27, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

    Reason

    Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process.

    Action

    On February 13, 2026, the firm notified affected consignees via Urgent Medical Device Recall letters delivered through First Class mail and email. Customers were instructed to destroy all affected ENFit G-Tube connectors and kits that contain the G-Tube connectors.

    Distribution

    Worldwide - US Nationwide and the countries of Canada.

    Quantity

    651,789