Class II — NIHON KOHDEN ORANGEMED, INC
| Recalling firm | Nihon Kohden OrangeMed, LLC |
|---|---|
| Registered facility | NIHON KOHDEN ORANGEMED, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 1,999 units |
| Distribution | Worldwide Distribution: US (nationwide) to states of: AZ, CA, NY, MA, VT, LA, DC, PA, FL, UT and OUS (countries) of: Brazil, Japan, Ireland, Poland, Scotland, Germany, Kazakhstan, Spain, Slovenia, Germany/Bulgaria, Russia, India, Palestine, Libya, Jordan Kuwait, Lebanon, Syria, Turkey, South Africa, United Arab Emirates, Mexico, Colombia, Peru, Costa Rica, Barbados, Ecuador, Bahamas, Bolivia, St K… |
| Initiated | 2021-07-20 |
| Classified | 2021-09-08 |
| Terminated | 2023-04-21 |
| Recall number | Z-2435-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — NIHON KOHDEN ORANGEMED, INC (Z-2435-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88411/
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