Lower riskMedical device recall · FDA · Published September 9, 2025
NOXBOX Nitric Oxide Delivery System Recall: Dose Fluctuations Risk
NOXBOX recalls NOxBOXi Nitric Oxide Delivery System (Model NOXBOX-I) due to potential dose fluctuations when device settings are incorrect. Affected users should contact manufacturer for details.
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
“NOXBOX Nitric Oxide Delivery System Recall: Dose Fluctuations Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51365-noxbox-nitric-oxide-delivery-system-recall-dose-fluctuations-risk. Based on FDA recall #Z-0028-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0028-2026%22&limit=1).
The FDA announced on Sept. 9, 2025, that NOXBOX LTD is recalling the NOxBOXi Nitric Oxide Delivery System due to potential dose fluctuations. The recall affects all serial numbers of the device distributed in Tennessee.
How to tell if you have it
Brand: NOXBOX
Product: NOxBOXi Nitric Oxide Delivery System
Model Numbers: NOXBOX-I, NOXBOXI (NBL), REQNOXBOXI (Linde)
UDI-DI: 05060541640009
Units affected: 1667
The hazard
Dose fluctuations may occur if the total flow through the device sensor is less than the minimum requirement of 0.5 LPM. Fluctuations have also been observed when used with Bunnel LifePulse HFJV systems or conventional ventilators at low service pressures, specific pressure differences, or breath rates of 300.
Context
GovInfoNow's records show NOXBOX LTD has issued five other recalls since May 3, 2023. Recent similar recalls include the Sept. 14, 2026 recall for potential irregular oxygen readings and the Aug. 19, 2026 recall for oxygen tubing leak risks. Other recent recalls of similar products include the Broselow Filled Organizer Recall (Dec. 15, 2025) and ICU Medical Plum Duo IV Pump Recall (April 29, 2026).
How to tell if you have this one
Check for model numbers NOXBOX-I or NOXBOXI on the device. The product was sold with UDI-DI code 05060541640009 and all serial numbers.
Brand
NOXBOX
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to NOXBOX LTD for specific instructions on how to verify your device model and next steps.
Where it went and when
Where it was distributed
Distributed in Tennessee.
Listed by the agency
Not listed
FDA distribution: “Domestic: TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA published this recall 36 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0028-2026 (September 9, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0028-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.