Use caution Medical device recall · FDA · Published May 3, 2023

NOXBOX Nitric Oxide Delivery System Recall: Risk of Gas Leak or Therapy Interruption

NOXBOX recalls specific nitric oxide delivery devices due to potential check valve misalignment causing gas leaks or therapy interruptions. Affected units have unique serial numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1667-2023Medical device NOXBOX ›

Use caution until it’s fixed

Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.

Take action

Contact the company

Recalling firmNOXBOX LTDUnit 1080, &; 1081 Galley Drive; Kent Science Park · Sittingbourne, United Kingdom

✎ GovInfoNow plain-language explainer

NOXBOX is recalling certain nitric oxide delivery systems that could malfunction due to a check valve issue. This might cause oxygen or nitric oxide leaks, or interrupt therapy, risking oxygen desaturation for patients. Read more at govinfonow.com/recall/58473-noxbox-nitric-oxide-delivery-system-recall-risk-of-gas-leak.

Source Summary by GovInfoNow · govinfonow.com/recall/58473-noxbox-nitric-oxide-delivery-system-recall-risk-of-gas-leak · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1667-2023

Cite this page

“NOXBOX Nitric Oxide Delivery System Recall: Risk of Gas Leak or Therapy Interruption.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58473-noxbox-nitric-oxide-delivery-system-recall-risk-of-gas-leak. Based on FDA recall #Z-1667-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1667-2023%22&limit=1).

NOXBOX LTD recalled NOxBOXi Nitric Oxide Delivery Systems, NOXBOX-I, and REQNOXBOX-I devices due to potential check valve misalignment causing gas leaks or therapy interruption. The Food and Drug Administration announced the Class I recall on May 3, 2023.

How to tell if you have it

Brand: NOXBOX
Product names: NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
UDI/DI: 5060541640009
Serial Numbers: NI101029 through NI103208 (as listed in record)
Distribution: Worldwide, including US Nationwide and Bahrain, Bolivia, Brazil, Ecuador, Finland, France, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Panama, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Turkey, UAE, United Kingdom

The hazard

The device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.

Context

GovInfoNow's records show NOXBOX LTD has 5 other recalls on record since 2023-07-19. Other recent recalls of similar products include NOxBOXi Nitric Oxide Delivery System: Potential for Irregular Oxygen Readings (2026-09-14), NOXBOX Nitric Oxide Delivery System Recall: Oxygen Tubing Leak Risk (2026-08-19), and NOXBOX Nitric Oxide Delivery System Recall: Button Errors Cause System Fault (2025-09-09). Other recent recalls of similar products include Datex-Ohmeda Aisys CS2 Anesthesia System Recall: Risk of Interrupted Anesthetic Delivery (2026-07-30), Datex-Ohmeda Aisys Anesthesia System Recall: Risk of Interrupted Anesthetic Delivery (2026-07-30), and Medline Oxygen Masks Recall: Tubing Disconnects Risk Shortness of Breath (2025-11-21).

How to tell if you have this one

Check your device's serial number against the list of affected units provided in the recall notice. The affected units have specific serial numbers starting with NI followed by numbers.

Brand
NOXBOX
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Compare your device's serial number to the list of affected serial numbers provided in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of Bahrain, Bolivia, Brazil, Ecuador, Finland, France, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Panama, Saudi Arabia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

May 3, 2023Firm started the recall
Jun 9, 2023FDA classified it Class I
Jun 21, 2023Published in FDA’s Enforcement Report
Oct 31, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/58473-noxbox-nitric-oxide-delivery-system-recall-risk-of-gas-leak">NOXBOX Nitric Oxide Delivery System Recall: Risk of Gas Leak or Therapy Interruption (GovInfoNow)</a>

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-1667-2023 (May 3, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1667-2023 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.