Recall Z-0267-2025— Nihon Kohden America Inc
Class II · Ongoing
Class II FDA medical device recall by Nihon Kohden America Inc, initiated 2024-09-18. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Nihon Kohden America Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-18
- Firm location
- Irvine, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.