CLASS II Device recall · Reported 15 Sep 2021 · FDA Enforcement Report
Nihon Kohden NKV-550 Ventilator recalled
Nihon Kohden Orangemed is recalling Nihon Kohden NKV-550 Ventilator, distributed nationwide in the US. The recall was initiated on 20 Jul 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2435-2021
- FDA event ID
- 88411
- Recalling firm
- Nihon Kohden Orangemed, Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2021
- FDA classified
- 8 Sep 2021
- Reported
- 15 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 20 Jul 2021 | Recall initiated by company | |
| 8 Sep 2021 | Classified by FDA | +50 days |
| 15 Sep 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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 Kitts & Nevis, St. Martin, Chile, Thailand, Laos, Philippines, Malaysia, Nepal and United Kingdom.
Nationwide ArizonaCaliforniaDistrict of ColumbiaFloridaLouisianaMassachusettsNew YorkPennsylvaniaUtahVermont
Questions about this recall
Is Nihon Kohden NKV-550 Ventilator recalled?
Yes. Nihon Kohden Orangemed recalled Nihon Kohden NKV-550 Ventilator on 20 Jul 2021. The recall is Class II and its status is Terminated. Recall number Z-2435-2021.
Why was it recalled?
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.
Which lots are affected?
All serial numbers between NKV5502019xxxx - NKV5502112xxxx and the following serial numbers below: NKV55019270055, NKV55019370098R, NKV55019430125R, NKV55019470156R, NKV55019470160, NKV55020130200, NKV55020140213R, NKV55020140226R, NKV55020140229, NKV55020150241, NKV55020150252, NKV55020160268, NKV55020160276, NKV55020160277, NKV55020160292R, NKV55020160296, NKV55020160297, NKV55020160304, NKV55020160307, NKV55020160308, NKV55020160310, NKV55020160312, NKV55020170317, NKV55020170318, NKV55020170325, NKV55020170335, NKV55020170336, NKV55020170341, NKV55020170342, NKV55020170343, NKV55020170346, NKV55020170347, NKV55020170349, NKV55020170350, NKV55020170352, NKV55020170354, NKV55020170357, NKV55020170360, NKV55020180365, NKV55020180366, NKV55020180369, NKV55020180370, NKV55020180371, NKV55020180372, NKV55020180373, NKV55020180374, NKV55020180375, NKV55020180376, NKV55020180378, NKV55020180379, NKV55020180381, NKV55020180383, NKV55020180384, NKV55020180385, NKV55020180387, NKV55020180391, NKV55020180392, NKV55020180396, NKV55020180397, NKV55020180398, NKV55020180399, NKV55020180400, NKV55020180401, NKV55020180402, NKV55020180403, NKV55020180405, NKV55020180406, NKV55020180408, NKV55020180409, NKV55020180410, NKV55020180411, NKV55020180412, NKV55020180413
Where was it sold?
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 Kitts & Nevis, St. Martin, Chile, Thailand, Laos, Philippines, Malaysia, Nepal and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other CPAP & Ventilators recalls
All 551| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |
| Device | CLASS I | Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | WI |