FDA recall record · openFDA

NOXBOX LTD

4 FDA recalls on record (2023–2025) — 4 device. 3 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine fl 1

Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is 1

Replacement of the internal Sample Pump due to high failure rates. 1

The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made t 1

Recalls

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I Class I 2025-09-09 NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I Class I 2025-09-09 NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device Class I 2023-05-03 NOxBOXi Nitric Oxide Delivery System Class II 2023-07-19

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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