Unrated Medical device recall · FDA · Published September 18, 2024

Nihon Kohden Adult Ear Clip SpO2 Sensor Recall: No FDA Approval in U.S

Nihon Kohden recalls adult ear clip SpO2 sensors without FDA approval for U.S. use. This device may not meet safety standards, but no specific action is required.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0268-2025Medical device Nihon Kohden ›

Recall notice

Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

Take action

Contact the company

Recalling firmNihon Kohden America Inc15353 Barranca Pkwy · Irvine, CA 92618-2216

✎ GovInfoNow plain-language explainer

Nihon Kohden is recalling adult ear clip SpO2 sensors that were sold without FDA approval in the U.S. This means the product may not meet safety standards, but no action is needed for consumers. Read more at govinfonow.com/recall/54006-nihon-kohden-adult-ear-clip-spo2-sensor-recall-no-fda.

Source Summary by GovInfoNow · govinfonow.com/recall/54006-nihon-kohden-adult-ear-clip-spo2-sensor-recall-no-fda · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0268-2025

Cite this page

“Nihon Kohden Adult Ear Clip SpO2 Sensor Recall: No FDA Approval in U.S.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54006-nihon-kohden-adult-ear-clip-spo2-sensor-recall-no-fda. Based on FDA recall #Z-0268-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0268-2025%22&limit=1).

The FDA announced on Sept. 18, 2024, that Nihon Kohden America Inc is recalling the Adult Ear Clip SpO2 Sensor due to lack of FDA market approval or clearance for distribution in the U.S., according to the FDA.

How to tell if you have it

Brand: Nihon Kohden
Product: Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip
Model number: 809030007
UDI-DI: 06970758500159
Lot numbers: All lot numbers
Units affected: 64

The hazard

The recalled devices lack FDA market approval or clearance to be distributed in the United States, according to the FDA.

Context

GovInfoNow's records show Nihon Kohden America Inc has issued four other recalls since Dec. 21, 2020. Other recent recalls of similar products include the Covidien Mon-a-Therm Stethoscope Recall (April 23, 2026), the Covidien Mon-a-Therm Temperature Probe Recall (April 23, 2026), and the Silent Nite Sleep Appliance Recall (April 27, 2026).

How to tell if you have this one

Check for the model number 809030007 on the device. The product was sold with UDI-DI: 06970758500159 and all lot numbers.

Brand
Nihon Kohden
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
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

Recall number	Product, codes & lots	Quantity
Z-0267-2025	Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box; Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers	67
Z-0268-2025	Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each; Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers	64

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model number 809030007 on the ear clip SpO2 sensor.

Where it went and when

Where it was distributed

Distributed in 29 states.

FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, New Hampshire, North Carolina, North Dakota, Oklahoma, Pennsylvania, South Carolina, Texas, Vermont, Washington, Wisconsin.

Recall timeline

FDA published this recall 49 days after the firm started it.

Sep 18, 2024Firm started the recall
Oct 30, 2024FDA classified it Class II
Nov 6, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/54006-nihon-kohden-adult-ear-clip-spo2-sensor-recall-no-fda">Nihon Kohden Adult Ear Clip SpO2 Sensor Recall: No FDA Approval in U.S (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0268-2025 (September 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0268-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.