Nihon Kohden America Inc. is recalling 131 units of forehead and ear clip SpO2 sensors because these medical devices were distributed in the U.S. without the required FDA market approval or clearance. The recall includes the Adult/Pediatric Forehead Disposable SpO2 Sensor (Model 809030006) and the Adult Ear Clip SpO2 Sensor (Model 809030007). These sensors are used to monitor oxygen levels in patients, and because they have not been vetted by the FDA, their safety and accuracy cannot be guaranteed. Consumers and healthcare providers should identify these specific models and contact the manufacturer for further guidance.
Devices without FDA clearance have not been reviewed for safety or performance, which may result in inaccurate oxygen monitoring or other malfunctions that could impact patient care.
Contact for guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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