Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Reported: November 6, 2024 Initiated: September 18, 2024 #Z-0267-2025
Product Description
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.
Details
- Recalling Firm
- Nihon Kohden America Inc
- Units Affected
- 67
- 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
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box. Recalled by Nihon Kohden America Inc. Units affected: 67.
Why was this product recalled? ▼
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2024. Severity: Moderate. Recall number: Z-0267-2025.
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