# FDA recall Z-0267-2025

> **Nihon Kohden America Inc** · Class II · device recall initiated 2024-09-18.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0267-2025
- **Recalling firm:** Nihon Kohden America Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-18
- **Report date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0267-2025

## Citation

> AI Analytics. FDA recall Z-0267-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0267-2025. Source: US FDA. Licensed CC0.

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