Nihon Kohden Adult Ear Clip SpO2 Sensors Recalled for Lack of FDA Clearance
Nihon Kohden America Inc. is recalling 64 Adult Ear Clip SpO2 Sensors (Model 809030007) due to lack of FDA market approval and clearance for U.S. distribution.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall without reported injuries or illnesses. However, it qualifies as a risk-of-harm product where injury has not yet been reported. The device is critical to patient care (oxygen saturation monitoring) and lacks FDA clearance to verify its safety and effectiveness.
Plain-English summary
Nihon Kohden America Inc. is recalling 64 units of its Adult Ear Clip SpO2 Sensor, Model 809030007, a reusable ear clip device with a 1.5-meter cable. The devices were distributed to healthcare facilities across multiple U.S. states.
The recall was issued because the devices lack FDA market approval and clearance for distribution in the United States. Without FDA clearance, these devices have not been verified to meet FDA standards for safety and effectiveness in measuring oxygen saturation.
The affected sensors, identified by Model 809030007 and UDI-DI 06970758500159, are included in this recall across all lot numbers. The devices were distributed to states including Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Maryland, Massachusetts, Michigan, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, Oklahoma, Pennsylvania, South Carolina, Texas, Vermont, Washington, and Wisconsin.
The recalled product
- Product
- Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
- Manufacturer
- Nihon Kohden America Inc
- Hazard
- lack-of-fda-clearance
- regulatory-non-compliance
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model num.: 809030007 UDI-DI: 06970758500159 All lot numbers
Distribution
Distributed in 29 states:
- 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
- WI
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