BEUDAMED
    FDA Enforcement Class I Ongoing

    NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

    Recall: Z-0029-2026 · Reported October 15, 2025

    Enforcement

    Recall Number
    Z-0029-2026
    Event ID
    97516
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NOXBOX LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2025
    Initiation Date
    September 9, 2025
    Classification Date
    October 6, 2025
    Address
    Unit 1, Eurolink Gateway; Castle Road, Sittingbourne, N/A, United Kingdom

    Description

    NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

    Reason

    The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

    Code Info

    Model Numbers: (1) NOXBOXI (NBL (Manufacturer)), (2) REQNOXBOXI (Linde (U.S. Distributor)); UDI-DI: 05060541640009; All serial numbers.

    Distribution

    Domestic: TN;

    Quantity

    1667 units