NOxBOXi Nitric Oxide Delivery System — Class I medical device recall Z-1667-2023
Terminated recall by NOXBOX LTD, reported 2023-06-21, distributed nationwide. Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails
| Recall number | Z-1667-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NOXBOX LTD, Sittingbourne, N/A, United Kingdom |
| Recall initiated | 2023-05-03 |
| Classified | 2023-06-09 |
| Reported by FDA | 2023-06-21 |
| Terminated | 2024-10-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BH, BO, BR, EC, ES, FI, FR, GB, HK, ID, IE, IL, IN, IT, KW, MX, MY, NL, NZ, PA, SA, SG, TR, TW, ZA |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 05060541640009 |
Product
NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Reason for recall
Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder gas changeover than expected or not at all. In a worst case scenario, there may be an interruption in therapy which could lead to oxygen desaturation of the patient and associated complications.
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-1667-2023. 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.