Nihon Kohden America Inc: Device Recall
Recall #Z-0268-2025 · 09/18/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0268-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Nihon Kohden America Inc
- Status
- Ongoing
- Date Initiated
- 09/18/2024
- Location
- Irvine, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64
Reason for Recall
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Product Description
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Distribution Pattern
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
Other Recalls by Nihon Kohden America Inc
- Class II: Risk 09/18/2024
- Class II: Risk 04/29/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.