FDA Device recall Z-0267-2025
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp by Nihon Kohden America, citing due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0267-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-18 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Nihon Kohden America |
| Distribution | 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 |
Product
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Reason
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Identifiers
| code_info | Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Nihon Kohden America
- Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03,…
FDA Device · Class II · 2026-10-14 · Nihon Kohden America - Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who ca…
FDA Device · Class II · 2024-11-13 · Nihon Kohden America - Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
FDA Device · Class II · 2024-11-06 · Nihon Kohden America - BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and…
FDA Device · Class II · 2024-06-12 · Nihon Kohden America - WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
FDA Device · Class II · 2021-03-10 · Nihon Kohden America
All Nihon Kohden America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0267-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.