Class I

Medical Device Recall: NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

NOXBOX LTD · September 9, 2025

Reason for Recall

The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

Distribution

Domestic: TN;

States Affected

TN

Quantity Affected

1667 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0029-2026

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.

NOXBOX LTD Medical Device Recall: NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I | SafeCheck