Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor — Class II medical device recall Z-0267-2025
Ongoing recall by Nihon Kohden America Inc, reported 2024-11-06, distributed in AL, AR, AZ, CA, CO, CT, FL, GA…. Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
| Recall number | Z-0267-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nihon Kohden America Inc, Irvine, CA, United States |
| Recall initiated | 2024-09-18 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Distributed | 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, WI |
| Quantity | 67 |
| UPC / GTIN / UDI-DI | 06970758500173 |
| Model numbers | 809030006 |
Product
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Reason for recall
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
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-0267-2025. 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.