NOxBOXi Nitric Oxide Delivery System — Class II medical device recall Z-2544-2025
Ongoing recall by NOXBOX LTD, reported 2025-09-17, distributed nationwide. Replacement of the internal Sample Pump due to high failure rates.
| Recall number | Z-2544-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | NOXBOX LTD, Sittingbourne, N/A, United Kingdom |
| Recall initiated | 2023-07-19 |
| Classified | 2025-09-09 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,667 units |
| UPC / GTIN / UDI-DI | 05060541640009 |
| Serial numbers | NI000000, NI100833, NI100839, NI100840, NI100841, NI100847, NI100848, NI100849, NI100850, NI100851, NI100852, NI100855, NI100858, NI100859, NI100861, NI100862, NI100865, NI100866, NI100868, NI100869, NI100872, NI100873, NI100875, NI100876, NI100878 and 475 more |
Product
NOxBOXi Nitric Oxide Delivery System
Reason for recall
Replacement of the internal Sample Pump due to high failure rates.
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-2544-2025. 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.