Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported June 21, 2023
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
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 c…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Noxbox LTD recalled NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device - a critical-severity action.
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device was recalled by Noxbox LTD in June 21, 2023. Reason: Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fail…. Check the official notice for the remedy. Verify recall #Z-1667-2023 with the FDA Devices before acting.
The recall
Noxbox LTD issued this critical-severity FDA Devices recall-Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fail….
- Critical
- severity level
- Class I
- classification
- June 21, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1667-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1667-2023) was formally reported on June 21, 2023, with the manufacturer initiating the action on May 3, 2023. It is classified under Critical severity (Class I), with a current status of Terminated. Noxbox LTD is listed as the recalling firm, operating out of Sittingbourne, N/A. Federal records list the affected scope as 548 (US); 208 (OUS).
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
548 (US); 208 (OUS)
Related Recalls
6
3 from same agency
Product description
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1667-2023 |
| Date reported | June 21, 2023 |
| Date initiated | May 3, 2023 |
| Recalling firm | Noxbox LTD |
| Firm location | Sittingbourne, N/A |
| Affected scope | 548 (US); 208 (OUS) |
| 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… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1667-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device. Recalled by Noxbox LTD. Units affected: 548 (US); 208 (OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 21, 2023. Severity: Critical. Recall number: Z-1667-2023.
Where was the recalled product distributed? ▼
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, Singapore, South Africa, Spain, Taiwan, Turkey, UAE, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1667-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 21, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.