Class II

Medical Device Recall: NOxBOXi Nitric Oxide Delivery System.

NOXBOX LTD · August 19, 2026

Reason for Recall

Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

Distribution

US Nationwide distribution in the state of Georgia.

States Affected

NATIONWIDE

Quantity Affected

1,547 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3165-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.