NOxBOXi Nitric Oxide Delivery System: Potential for Irregular Oxygen Readings
NOXBOX LTD recalls 1,667 NOxBOXi Nitric Oxide Delivery Systems (Model NOXBOX-I) with serial numbers starting from NI100825 to NI103220. These units may cause irregular oxygen readings due to a manufacturing issue with oxygen sensors. Stop using immediately.
Use caution until it’s fixed
Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxygen sensors.
What happened, in plain English
NOXBOX LTD has recalled 1,667 units of their NOxBOXi Nitric Oxide Delivery System (Model NOXBOX-I) because certain oxygen sensors may provide irregular oxygen readings. This could lead to inaccurate monitoring of oxygen levels, which is critical for users relying on the device. Read more at govinfonow.com/recall/1449217-noxbox-ltd-recalls-noxboxi-nitric-oxide-delivery-system-model-number.
Source Summary by GovInfoNow · govinfonow.com/recall/1449217-noxbox-ltd-recalls-noxboxi-nitric-oxide-delivery-system-model-number · Updated October 14, 2026 · FDA enforcement record: FDA #Z-3306-2026
Cite this page
“NOxBOXi Nitric Oxide Delivery System: Potential for Irregular Oxygen Readings.” GovInfoNow, updated October 14, 2026. https://govinfonow.com/recall/1449217-noxbox-ltd-recalls-noxboxi-nitric-oxide-delivery-system-model-number. Based on FDA recall #Z-3306-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3306-2026%22&limit=1).
Why it’s dangerous
The device's oxygen sensors may provide irregular oxygen readings due to a manufacturing issue. This could lead to inaccurate monitoring of oxygen levels, which is critical for users who depend on the device for medical purposes.
Who’s affected
Users of the NOxBOXi Nitric Oxide Delivery System with serial numbers from NI100825 to NI103220 are affected. Those who rely on the device for medical oxygen monitoring are at the highest risk.
How to tell if you have this one
Check your NOxBOXi Nitric Oxide Delivery System for a serial number starting with 'NI' and ending with numbers between 100825 and 103220. The device was sold nationwide in Georgia starting in 2026.
- Brand
NOXBOX- Category
Medical device
What to do — step by step
Stop using it now
Immediately stop using the NOxBOXi Nitric Oxide Delivery System if it has a serial number from NI100825 to NI103220.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of Georgia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 23 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
When was this recall issued?
This recall was issued on September 14, 2026.
Where was the product distributed?
The product was distributed nationwide in the state of Georgia.
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Where this comes from
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-3306-2026 (September 14, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3306-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 14, 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.