NOXBOX LTD: Device Recall

Recall #Z-0029-2026 · 09/09/2025

Class I: Dangerous

Recall Details

Recall Number: Z-0029-2026
Classification: Class I
Product Type: Device
Recalling Firm: NOXBOX LTD
Status: Ongoing
Date Initiated: 09/09/2025
Location: Sittingbourne, United Kingdom
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1667 units

Reason for Recall

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.

Product Description

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

Distribution Pattern

Domestic: TN;

Other Recalls by NOXBOX LTD

Class I: Dangerous 09/09/2025

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).

View all recalls by NOXBOX LTD →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.