Z-0268-2025 Class II Ongoing
FDA device recall Z-0268-2025 was initiated by Nihon Kohden America Inc on September 18, 2024 and is designated Class II. Reason for recall: Due to oximeters not having FDA market approval or clearance to distribute in the U.S. The recall status is ongoing. Affected quantity: 64.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2024
- Initiation Date
- September 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64
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.
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
Code Information
Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers