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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- nitric-oxide-leak
- oxygen-leak
- therapy-interruption
- oxygen-desaturation
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27