FDA classified NOxBOX's correction of the NOxBOXi nitric oxide delivery system as Class II on September 18. The oxygen tubing inside the NOxMixer module can fail, or its connection can come loose. A leak there raises the delivered nitric oxide dose or interrupts therapy outright.
FDA lists oxygen desaturation, elevated pulmonary artery pressure and methemoglobinemia as the consequences, and singles out neonates with congenital heart disease. NOxBOX had reported no serious injuries or deaths as of August 12, 2026. Affected units carry UDI 05060541640016, with the serial number list posted for download.
The correction is a labeling change, not a device replacement. Sites are told to verify that oxygen supply tubing is securely connected, run pre-use system checks, confirm the flowmeter works and keep a backup device on hand.
The same platform drew a Class I recall in 2023 under recall number Z-1667-2023, covering 548 US units, after check valve misalignment risked nitric oxide and oxygen leaks. Two gas path failures on one product in three years is the kind of history a reviewer reads before the next submission.