Nihon Kohden America Inc Recalls
4 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (4)
- Class II
September 18, 2024
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
- Class II
September 18, 2024
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
- Class II
April 29, 2024
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital sig
Due to software issue the device may give false "SpO2 Probe Failure" alarm
- Class II
April 29, 2022
Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures
Due to products being shipped/distributed to customers after the products expiration date had past.
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