BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Pyxis MedStation 4000 REF: 303 Medication cabinet

    Recall: Z-2297-2026 · Reported June 10, 2026

    Enforcement

    Recall Number
    Z-2297-2026
    Event ID
    98895
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 10, 2026
    Initiation Date
    April 30, 2026
    Classification Date
    June 3, 2026
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    BD Pyxis MedStation 4000 REF: 303 Medication cabinet

    Reason

    Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

    Code Info

    All Serial Numbers/UDI:10885403512629

    Distribution

    US: Nationwide OUS: AE, AU, BE, BH, BR, CA, CL, ES, GB, IT, KW, MA, MX, NZ, PT, QA, SA, SG, TH, TW

    Quantity

    1 unit