NOxBOXi Nitric Oxide Delivery System
The NOxBOXi Nitric Oxide Delivery System may have irregular oxygen readings due to a manufacturing issue.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
NOXBOX LTD is recalling the NOxBOXi Nitric Oxide Delivery System, Model Number NOXBOX-I, due to a manufacturing issue affecting certain oxygen sensors that may cause irregular oxygen readings. The recall involves 1,667 units and was initiated by the company on September 14, 2026, with the FDA adding it to the Enforcement Report on September 25, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number, UDI-DI and lot code listed under your product.
NOxBOXi Nitric Oxide Delivery System.
- Model
- NOXBOX-I
- UDI-DI
- 05060541640009
- Lot
- 2026
Details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Georgia.
- Event ID
- 99816
- Recall No.
- Z-3306-2026
- Company
- NOXBOX LTDSittingbourne, United Kingdom
- Hazard
- Manufacturing deviation
- Quantity recalled
- 1,667 units
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
