FDA-Device2026-09-23Class IIPROCESSING DEFECT
NOxBOXi Nitric Oxide Delivery System recalled for oxygen tubing leak risk
What this means
The oxygen tubing in certain NOxBOXi Nitric Oxide Delivery Systems may leak or disconnect, which could reduce oxygen flow to the patient. This happens because the tubing or its connection can fail. The recall affects 1,547 units with specific serial numbers.
- Check if your NOxBOXi system serial number is listed in the recall (NM100825 through NM101253 range).
- Stop using the device and contact your healthcare provider or the supplier for a replacement or repair.
- Monitor the patient for any signs of low oxygen levels if the device was in use.
The agency's original wording
Hazard
Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of Georgia.
Affected count
1,547 units
Manufactured in
Unit 1, Eurolink Gateway; Castle Road, Sittingbourne, N/A, United Kingdom
Products
NOxBOXi Nitric Oxide Delivery System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3165-2026Want us to check the next one for you?
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