Noxbox Ltd FDA Recalls

5 recalls on file across devices, 3 of them Class I and 4 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
NOxBOXi Nitric Oxide Delivery System.Class IIAug 19, 2026Potential for oxygen tubing leaks due to failure of the tubi	Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen	Class IIDevices	Aug 19, 2026
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-IClass ISep 9, 2025Fluctuations may be more likely to occur if the total flow t	Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to de	Class IDevices	Sep 9, 2025
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-IClass ISep 9, 2025The unexpected internal fault / system diagnostic error to r	The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections	Class IDevices	Sep 9, 2025
NOxBOXi Nitric Oxide Delivery SystemClass IIJul 19, 2023Replacement of the internal Sample Pump due to high failure	Replacement of the internal Sample Pump due to high failure rates.	Class IIDevices	Jul 19, 2023
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery DeviceClass IMay 3, 2023Device may experience malfunctions due to misalignment of th	Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails	Class IDevices	May 3, 2023