NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I Recall
Issued October 15, 2025 · NOXBOX LTD
In October 2025, NOXBOX LTD recalled the NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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).
What you should do
- 1 Stop using NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact NOXBOX LTD to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- NOXBOX LTD
- Category
- Health
- Recall date
- October 15, 2025
- Units affected
- Not reported
- Sold at
- Domestic: TN
- Recall number
- FDA-Z-0028-2026
- Made in
- United Kingdom
- Issuing agency
- FDA
In context
- NOXBOX LTD has 1 recall in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.