Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model… recallZ-0268-2025 · Nihon Kohden America Inc · initiated Sep 18, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nihon Kohden America Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
FDA root cause category: No Marketing Application
What the company is doing
On 10/07/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" via certified mail or FedEx informing customers that the Sp02 sensor's intended use was not reviewed/evaluated by the FDA and does not have market approval or clearance for distribution in the U.S. Customers are instructed to: 1. Identify any Caremed SpO2 sensor packages you have in inventory and cease use of the affected product. 2. Complete the attached Medical Device Notification Return Response Form 3. Email the completed Medical Device Notification Return Response Form back to NKA Technical Services at [email protected]. Nihon Kohden is requesting all unused stock be returned to Nihon Kohden and a full refund will be issued for unused product. Please contact Nihon Kohden Technical Support to coordinate the return of the affected product. If you have questions about this notification or the form below, please call Nihon Kohden America at 1-800-325-0283, Option 2 (M-F, 8am-5pm PDT) or email [email protected].
Recall details
- Recall number
- Z-0268-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 18, 2024
- Posted by the FDA
- Oct 30, 2024
- Recalling firm
- Nihon Kohden America Inc
- Quantity
- 64
- Product code
- DQA
- 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
Product description
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Code information (models, lots, serial numbers)
Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Caremed C403-01Shenzhen Caremed Medical Technology Co., Ltd. · Oximeter1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95426).
- Z-0267-2025 · Open, ClassifiedNihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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