NOxBOXi Nitric Oxide Delivery System
The NOxBOXi Nitric Oxide Delivery System has potential oxygen tubing leaks that may cause oxygen desaturation.
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, based in Sittingbourne, United Kingdom, recalled the NOxBOXi Nitric Oxide Delivery System due to potential oxygen tubing leaks from failure of the tubing or tubing connection, which may lead to oxygen desaturation. The company began the recall on August 19, 2026, and the FDA added it to the Enforcement Report on September 15, 2026.
The recall involved 1,547 units distributed in Georgia. The FDA classified the recall on September 15, 2026, and it was in the weekly enforcement report on September 23, 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?
Affected if its UDI-DI matches.
NOxBOXi Nitric Oxide Delivery System.
- UDI-DI
- 05060541640009
Details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Georgia.
- Event ID
- 99621
- Recall No.
- Z-3165-2026
- Company
- NOXBOX LTDSittingbourne, United Kingdom
- Hazard
- Device defect
- Quantity recalled
- 1,547 units
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
