FDA Medical devices recall ·
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007… recall
- Recall number
- Z-0268-2025
- Date
- (initiated September 18, 2024)
- Company / brand
- Nihon Kohden America Inc
15353 Barranca Pkwy, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 64
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Why was it recalled?
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers
Distribution
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
States: Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Hawaii Iowa Idaho Illinois Kansas Massachusetts Maryland Michigan Missouri Montana North Carolina North Dakota Nebraska New Hampshire Oklahoma Pennsylvania South Carolina Texas Vermont Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0268-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.