[Recalled] NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I — Fluctuations may be more likely to occur if the total flow through the device s… | FDA 2025-09-09
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I |
|---|---|
| Brand / manufacturer | NOXBOX LTD |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0028-2026 |
| Country of notice | United Kingdom |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 09 September 2025 |
| EAN / barcode | 05060541640009 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard 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 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).
This Class I recall concerns device products distributed in United Kingdom and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
Related recalls from NOXBOX LTD
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.