Sittingbourne, N/A, United Kingdom
NOXBOX LTD recalls
6 recalls recorded since 2018, most recently on 14 September 2026. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)5
Terminated or completed1
Class I (FDA)3
Ongoing Class II Medical devices
- Recall started
- 14 September 2026
- Reason
- Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
- Distribution
- US Nationwide distribution in the state of Georgia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3306-2026
- NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Ongoing Class II Medical devices
- Recall started
- 19 August 2026
- Reason
- Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
- Distribution
- US Nationwide distribution in the state of Georgia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3165-2026
- NOxBOXi Nitric Oxide Delivery System.
Ongoing Class I Medical devices
- Recall started
- 9 September 2025
- 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).
- Distribution
- Domestic: TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0028-2026
- NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Ongoing Class I Medical devices
- Recall started
- 9 September 2025
- 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.
- Distribution
- Domestic: TN;
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0029-2026
- NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Ongoing Class II Medical devices
- Recall started
- 19 July 2023
- Reason
- Replacement of the internal Sample Pump due to high failure rates.
- Distribution
- US Nationwide distribution in the state of TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2544-2025
- NOxBOXi Nitric Oxide Delivery System
Terminated Class I Medical devices
- Recall started
- 3 May 2023
- Terminated
- 31 October 2024
- Reason
- Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Bahrain, Bolivia, Brazil, Ecuador, Finland, France, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Panama, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Turkey, UAE, Unite
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1667-2023
- NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.