BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

    Recall: Z-0504-2026 · Reported November 26, 2025

    Enforcement

    Recall Number
    Z-0504-2026
    Event ID
    97737
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 26, 2025
    Initiation Date
    October 14, 2025
    Classification Date
    November 14, 2025
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;

    Reason

    BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.

    Code Info

    Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;

    Distribution

    Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Singapore, Hong Kong.

    Quantity

    4180000 units