Nihon Kohden America Inc: Device Recall
Recall #Z-0267-2025 · 09/18/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0267-2025
- 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
- 67
Reason for Recall
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Product Description
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
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.