Recall Z-0268-2025— 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 Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each. 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 Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
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.