Irvine, CA, United States
Nihon Kohden America Inc recalls
6 recalls recorded since 2018, most recently on 8 September 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)6
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 8 September 2026
- Reason
- Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN. KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NL, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, QA, WA, WI, WV and WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0089-2027
- Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40 Product Description: The device
Ongoing Class II Medical devices
- Recall started
- 18 September 2024
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0268-2025, Z-0267-2025
- Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
- Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Ongoing Class II Medical devices
- Recall started
- 29 April 2024
- Reason
- Due to software issue the device may give false "SpO2 Probe Failure" alarm
- Distribution
- U.S. Nationwide distribution in the state of IA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2025-2024
- 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 signs monitoring within
Ongoing Class II Medical devices
- Recall started
- 29 April 2022
- Reason
- Due to products being shipped/distributed to customers after the products expiration date had past.
- Distribution
- U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0314-2025
- 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. The device is inte
Ongoing Class II Medical devices
- Recall started
- 8 January 2021
- Reason
- Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
- Distribution
- US - AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS,KY, LA, ME, MA, MD, MI, MS, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA WI, WV and WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1162-2021
- WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
Ongoing Class II Medical devices
- Recall started
- 21 December 2020
- Reason
- Medical device non-conformance to electrical safety standard (IEC 60601-1).
- Distribution
- US Nationwide Distribution - CA, CO, CT, FL, ID, IL, IN, MA, MD, MI, MO, NC, NM, NY, SC, TX, TN, UT, VA, VT and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0865-2021
- PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplif
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.