Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported October 15, 2025
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM.…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Noxbox LTD recalled NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I - a critical-severity action.
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I was recalled by Noxbox LTD in October 15, 2025. Reason: Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to d…. Check the official notice for the remedy. Verify recall #Z-0028-2026 with the FDA Devices before acting.
The recall
Noxbox LTD issued this critical-severity FDA Devices recall-Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to d….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- October 15, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0028-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0028-2026) was formally reported on October 15, 2025, with the manufacturer initiating the action on September 9, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Noxbox LTD is listed as the recalling firm, operating out of Sittingbourne. Federal records list the affected scope as 1667 units.
The documented reason for this recall is: Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have bee… Distribution data in the federal record shows the product reached: Domestic: TN. 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
1667 units
Related Recalls
6
3 from same agency
Product description
NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Reason for recall
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0028-2026 |
| Date reported | October 15, 2025 |
| Date initiated | September 9, 2025 |
| Recalling firm | Noxbox LTD |
| Firm location | Sittingbourne |
| Affected scope | 1667 units |
| Distribution | Domestic: TN |
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-0028-2026) 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; Model Numbers: NOXBOX-I. Recalled by Noxbox LTD. Units affected: 1667 units.
Why was this product recalled? ▼
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 15, 2025. Severity: Critical. Recall number: Z-0028-2026.
Where was the recalled product distributed? ▼
Distribution: Domestic: TN.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0028-2026) 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
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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 October 15, 2025. 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.