BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-0028-2026 · Reported October 15, 2025

    Enforcement

    Recall Number
    Z-0028-2026
    Event ID
    97517
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    NOXBOX LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    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

    Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

    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