NOxBOXi Nitric Oxide Delivery System — Class I medical device recall Z-0029-2026
Ongoing recall by NOXBOX LTD, reported 2025-10-15, distributed in TN. The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections
| Recall number | Z-0029-2026 |
|---|---|
| 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
The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.
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-0029-2026. 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.