Nitric Oxide Delivery System check valve misalignment risk
NOxBOXi Nitric Oxide Delivery System devices may malfunction due to misaligned check valves, risking gas leaks and therapy interruption. This could lead to oxygen desaturation if the device fails during patient use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I device recall with potential for therapy interruption and oxygen desaturation in patients. No illnesses or deaths reported in the source material, but the risk of harm in clinical use justifies the Severe classification.
Plain-English summary
The FDA is recalling NOxBOXi Nitric Oxide Delivery System devices (models NOXBOX-I and REQNOXBOX-I) manufactured by NOXBOX LTD. The affected devices may experience malfunctions due to misalignment of the check valve in the manifold.
If the device malfunctions, patients may experience nitric oxide leaks, oxygen gas leaks, or unexpected changes in cylinder gas supply. In the worst case, therapy may be interrupted entirely, potentially leading to oxygen desaturation and serious patient complications.
A total of 548 units were distributed in the United States and 208 units were distributed internationally to multiple countries. Patients currently using an affected device should contact their healthcare provider immediately if they experience any signs of device malfunction or unusual operation. Institutions and healthcare providers should refer to the FDA recall notice for the complete list of affected serial numbers.
The recalled product
- Product
- NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
- Manufacturer
- NOXBOX LTD
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · NOXBOX LTD
See all →- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Tubing Leak Risk
FDA (Devices) · 2026-09-23
- CriticalNitric oxide delivery systems recalled over dose fluctuations at low flow
FDA (Devices) · 2025-10-15
- CriticalNitric oxide systems recalled over fault from rapid button presses
FDA (Devices) · 2025-10-15
- ModerateNitric oxide delivery systems recalled to replace sample pumps failing at high rates
FDA (Devices) · 2025-09-17
Similar recalls
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Tubing Leak Risk
FDA (Devices) · 2026-09-23
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- CriticalNitric oxide delivery systems recalled over dose fluctuations at low flow
FDA (Devices) · 2025-10-15
- ModerateNitric oxide delivery systems recalled to replace sample pumps failing at high rates
FDA (Devices) · 2025-09-17
- CriticalNitric oxide systems recalled over fault from rapid button presses
FDA (Devices) · 2025-10-15
- HighCAREstream ProNox Nitrous Oxide Delivery Systems Recalled for High Gas Levels
FDA (Devices) · 2018-08-29