NOxBOXi Nitric Oxide Delivery System — Class I medical device recall Z-0028-2026
Ongoing recall by NOXBOX LTD, reported 2025-10-15, distributed in TN. Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to de
| Recall number | Z-0028-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NOXBOX LTD, Sittingbourne, United Kingdom |
| Recall initiated | 2025-09-09 |
| Classified | 2025-10-06 |
| Reported by FDA | 2025-10-15 |
| Distributed | TN |
| Quantity | 1,667 units |
| UPC / GTIN / UDI-DI | 05060541640009 |
Product
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0028-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.