NOXBOXi Nitric Oxide Delivery System Recall: High Sample Pump Failure Rates
NOXBOX recalls NOxBOXi Nitric Oxide Delivery Systems with high internal Sample Pump failure rates. Affected units have specific serial numbers listed in the recall notice.
Lower-risk recall
Replacement of the internal Sample Pump due to high failure rates.
Contact the company
What happened, in plain English
NOXBOX is recalling its NOxBOXi Nitric Oxide Delivery Systems due to high failure rates in the internal Sample Pump. This could lead to improper delivery of nitric oxide, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/57631-noxboxi-nitric-oxide-delivery-system-recall-high-sample-pump-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/57631-noxboxi-nitric-oxide-delivery-system-recall-high-sample-pump-failure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2544-2025
Cite this page
“NOXBOXi Nitric Oxide Delivery System Recall: High Sample Pump Failure Rates.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57631-noxboxi-nitric-oxide-delivery-system-recall-high-sample-pump-failure. Based on FDA recall #Z-2544-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2544-2025%22&limit=1).
Why it’s dangerous
The internal Sample Pump has a high failure rate, which may cause the device to deliver nitric oxide incorrectly. This could lead to improper treatment effectiveness but does not pose an immediate safety hazard like fire or injury.
Who’s affected
Users of the NOxBOXi Nitric Oxide Delivery System with the listed serial numbers are affected. Most at risk are individuals using this device for medical treatment.
How to tell if you have this one
Check if your NOxBOXi Nitric Oxide Delivery System has a serial number listed in the provided list (e.g., NI102738, NI103021, etc.).
- Brand
NOXBOX- Category
Medical device
What to do — step by step
Check Your Serial Number
Compare your device's serial number with the list of affected serial numbers provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-2544-2025 (July 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2544-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.