Nihon Kohden NKV-550 Ventilator — Class II medical device recall Z-2435-2021
Terminated recall by NIHON KOHDEN ORANGEMED, INC, reported 2021-09-15, distributed nationwide. Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise f
| Recall number | Z-2435-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NIHON KOHDEN ORANGEMED, INC, Santa Ana, CA, United States |
| Recall initiated | 2021-07-20 |
| Classified | 2021-09-08 |
| Reported by FDA | 2021-09-15 |
| Terminated | 2023-04-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BB, BG, BO, BR, BS, CL, CO, CR, DE, EC, ES, GB, IE, IN, JO, JP, KW, LB, MX, MY, NP, PE, PH, PL, RU, SI, TH, TR, ZA |
| Quantity | 1,999 units |
| UPC / GTIN / UDI-DI | 00843685100012 |
| Model numbers | 0344, NKV-550-U |
Product
Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support.
Reason for recall
Potential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a High Air/O2 Inlet Pressure alarm, a High/Low O2 alarm, or could not pass device Check prior to use.
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-2435-2021. 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.