Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Summary
The FDA issued a Class II for Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable S by Nihon Kohden America Inc. Reason: Due to oximeters not having FDA market approval or clearance to distribute in the U.S..
Details
Source
Device Recall
External ID
Z-0268-2025
Action Date
2024-11-06
Status
Ongoing
Category
device
Product Description
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Lot/Code Info: Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers
Quantity Affected: 64
Reason for Recall
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-18
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Nihon Kohden America Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Nihon Kohden America Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nihon Kohden America Inc have FDA actions?
Nihon Kohden America Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0268-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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