Brand
Nihon Kohden America Inc
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Nihon Kohden America Inc and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-11-13FDA-DeviceClass IIAdult 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. The device is intended for single patient use only.
Due to products being shipped/distributed to customers after the products expiration date had past.
- 2024-11-06FDA-DeviceClass IINihon 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.
- 2024-11-06FDA-DeviceClass IINihon 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.
- 2024-06-12FDA-DeviceClass IIBSM-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 signs monitoring within a medical facility.
Due to software issue the device may give false "SpO2 Probe Failure" alarm
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