NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

Recall date

September 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0029-2026

FDA classification

Class I

Brand / firm

NOXBOX LTD

Sold / distributed

Domestic: TN;

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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