FDA-Device2026-10-07Class IIPROCESSING DEFECT
NOxBOXi Nitric Oxide Delivery System recalled for irregular oxygen sensor readings
What this means
Certain NOxBOXi Nitric Oxide Delivery System units (Model NOXBOX-I) may provide inaccurate oxygen readings due to a manufacturing issue with the oxygen sensors. The affected units are identified by specific serial numbers starting with NI100825 through NI101636.
- Check if your device serial number matches the affected list provided by NOxBOX LTD
- Contact NOxBOX LTD or your device supplier for instructions on repair or replacement
- Do not rely on oxygen readings from an affected device without independent verification
The agency's original wording
Hazard
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of Georgia.
Affected count
1,667 units
Manufactured in
Unit 1, Eurolink Gateway; Castle Road, Sittingbourne, United Kingdom
Products
NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3306-2026More Noxbox recalls
- FDA-Device2026-09-23NOxBOXi Nitric Oxide Delivery System recalled for oxygen tubing leak risk
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