BEUDAMED
    FDA Recall Open, Classified

    Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

    Recall: Z-1312-2026 · Initiated December 24, 2025

    Recall

    Recall Number
    Z-1312-2026
    Event Number
    98285
    FEI Number
    1417592
    Product Code
    OFR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 24, 2025
    Posted
    February 6, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline 14 Fr Suction Catheter Kits SKU DYND40972 - respiratory convenience kit

    Reason

    A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.

    Action

    On December 24, 2025, the firm notified customers of the recall via email and first-class mail. Medline instructed customers to request stickers to over-label the affected kits with a warning label indicating to remove the affected component and replace it with product from supply.

    Distribution

    Distribution US nationwide and Canada.

    Quantity

    141,971