NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Medical device recall Z-1667-2023. Published in FDA’s Enforcement Report on Jun 21, 2023.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 21, 2023. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 548 (US); 208 (OUS) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
548 (US); 208 (OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI/DI: 5060541640009 Serial Numbers distributed in US: NI101029 NI102476 NI102518 NI102560 NI102594 NI102629 NI101388 NI102477 NI102519 NI102561 NI102595 NI102630 NI101392 NI102478 NI102520 NI102562 NI102596 NI102631 NI101441 NI102479…
Every code shown here, 2,000 characters
UDI/DI: 5060541640009 Serial Numbers distributed in US: NI101029 NI102476 NI102518 NI102560 NI102594 NI102629 NI101388 NI102477 NI102519 NI102561 NI102595 NI102630 NI101392 NI102478 NI102520 NI102562 NI102596 NI102631 NI101441 NI102479 NI102522 NI102563 NI102597 NI102632 NI101562 NI102480 NI102525 NI102564 NI102598 NI102633 NI101679 NI102481 NI102528 NI102565 NI102599 NI102634 NI101703 NI102482 NI102530 NI102567 NI102600 NI102635 NI101760 NI102483 NI102531 NI102569 NI102601 NI102636 NI101806 NI102484 NI102535 NI102571 NI102602 NI102637 NI101881 NI102485 NI102537 NI102573 NI102604 NI102639 NI101927 NI102486 NI102538 NI102574 NI102605 NI102640 NI102024 NI102487 NI102539 NI102575 NI102606 NI102641 NI102097 NI102493 NI102540 NI102576 NI102608 NI102642 NI102111 NI102495 NI102541 NI102577 NI102610 NI102646 NI102193 NI102496 NI102542 NI102578 NI102611 NI102647 NI102255 NI102497 NI102544 NI102579 NI102613 NI102649 NI102311 NI102498 NI102545 NI102580 NI102614 NI102652 NI102394 NI102499 NI102546 NI102581 NI102615 NI102654 NI102397 NI102500 NI102547 NI102582 NI102616 NI102655 NI102398 NI102502 NI102548 NI102583 NI102617 NI102656 NI102436 NI102504 NI102550 NI102584 NI102618 NI102657 NI102438 NI102506 NI102551 NI102585 NI102619 NI102658 NI102444 NI102509 NI102552 NI102586 NI102620 NI102659 NI102445 NI102510 NI102553 NI102587 NI102621 NI102660 NI102463 NI102511 NI102554 NI102588 NI102622 NI102661 NI102466 NI102512 NI102555 NI102589 NI102623 NI102662 NI102467 NI102513 NI102556 NI102590 NI102625 NI102663 NI102473 NI102514 NI102557 NI102591 NI102626 NI102664 NI102474 NI102515 NI102558 NI102592 NI102627 NI102665 NI102475 NI102517 NI102559 NI102593 NI102628 NI102666 NI102667 NI102706 NI102742 NI102775 NI102810 NI102855 NI102668 NI102707 NI102743 NI102776 NI102811 NI102856 NI102669 NI102708 NI102744 NI102777 NI102812 NI102858 NI102670 NI102709 NI102745 NI102778 NI102813 NI102859 NI102671 NI102710 NI102746 NI102779 NI102814 NI102860 NI102672 NI102711 NI102747 NI102780 NI102815 NI102861…
FDA’s list runs to 4,492 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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, Singapore, South Africa, Spain, Taiwan, Turkey, UAE, United Kingdom.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 3, 2023.
- FDA classified it on Jun 9, 2023.
- FDA’s Enforcement Report published it on Jun 21, 2023.
- FDA terminated it on Oct 31, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- NOXBOX LTD, of Sittingbourne, United Kingdom.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,492 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.