CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m recalled
Nihon Kohden America is recalling Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m, distributed in 29 states. The recall was initiated on 18 Sep 2024 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-0267-2025
- FDA event ID
- 95426
- Recalling firm
- Nihon Kohden America, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Sep 2024
- FDA classified
- 30 Oct 2024
- Reported
- 6 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 18 Sep 2024 | Recall initiated by company | |
| 30 Oct 2024 | Classified by FDA | +42 days |
| 6 Nov 2024 | 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
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
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 Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Where it was distributed
U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, and WI. O.U.S.: N/A
AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisKansasMassachusettsMarylandMichiganMissouriMontanaNorth CarolinaNorth Dakota
Questions about this recall
Why was it recalled?
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Which lots are affected?
Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers
Where was it sold?
U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, and WI. O.U.S.: N/A
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 26 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 products in this recall event
1 other product · FDA event 95426This product is part of a recall event; the main page for the event is Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter recalled | Nihon Kohden America | Device Malfunction | 29 states |
More recalls from Nihon Kohden America
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Nihon Kohden CNS-6200 Series Central Nurse Station recalled | Nihon Kohden America | Device Malfunction | Nationwide |
| Device | CLASS II | Adult Cap-ONE Biteblock recalled by Nihon Kohden America | Nihon Kohden America | Other | Nationwide |
| Device | CLASS II | Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter recalled | Nihon Kohden America | Device Malfunction | 29 states |
| Device | CLASS II | BSM-3000 Series Bedside Monitor recalled by Nihon Kohden America | Nihon Kohden America | Device Malfunction | Nationwide |
| Device | CLASS II | WMTS Telemetry Receiver, Multiple Patient Receiver recalled | Nihon Kohden America | Other | 46 states |
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