The Recall Desk

Manufacturer

Nihon Kohden America Inc

10 recalls in our database name Nihon Kohden America Inc as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2024-11-13

Of the 10 recalls from Nihon Kohden America Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

  • ModerateFDA (Devices)·Z-0314-2025·2024-11-13

    Adult Cap-ONE Biteblock devices recalled for expired product distribution

    Nihon Kohden America Inc is recalling 17 Adult Cap-ONE Biteblock devices shipped after expiration dates. The single-use devices are intended for sampling CO2 and administering oxygen during endoscopy procedures.

    Product
    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 intended for single patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0267-2025·2024-11-06

    Nihon Kohden SpO2 Sensor Recalled Lacking FDA Market Approval

    Nihon Kohden America is recalling its Adult/Pediatric Forehead Disposable SpO2 Sensor (Model 809030006) because the device was distributed without FDA market approval or clearance.

    Product
    Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0268-2025·2024-11-06

    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.

    Product
    Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2025-2024·2024-06-12

    Bedside Monitor Software Issue Causes False Oxygen Saturation Probe Failure Alarms

    Nihon Kohden's BSM-3000 Series Bedside Monitors may produce false SpO2 probe failure alarms due to a software issue. Healthcare facilities should contact the manufacturer for guidance.

    Product
    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 a medical facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1162-2021·2021-03-10

    Nihon Kohden Telemetry Recalled for Incorrect Date Stamp or No Data Transfer

    Nihon Kohden America Inc is recalling WMTS Telemetry Receivers because they may display incorrect date stamps or fail to transfer data.

    Product
    WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDI
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-0865-2021·2021-02-03

    Nihon Kohden PSG-1100 Sleep Diagnostic System Recalled for Electrical Safety Non-Conformance

    Nihon Kohden America Inc is recalling 189 PSG-1100 Sleep Diagnostic Systems because they do not meet the IEC 60601-1 electrical safety standard.

    Product
    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 amplifier intended to record the electrical activity of the brain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2017·2017-04-19

    Nihon Kohden Bedside Monitor Recall for Pause Function Defect

    Nihon Kohden America Inc is recalling 654 bedside monitors because the pause function on central monitors fails to automatically resume when connected to specific Life Scope G9 units.

    Product
    Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2016·2016-02-24

    Nihon Kohden MEE-1000A Neuromaster Accessories Recalled for Defective Circuit Boards

    Nihon Kohden America Inc is recalling MEE-1000A Neuromaster accessories due to defective printed circuit boards that failed to prevent unintentional current flow.

    Product
    MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1543-2015·2015-05-06

    Nihon Kohden Remote Network Station Recall for Alarm Failure

    Nihon Kohden America is recalling 208 Remote Network Station units because they may fail to sound alarms for critical patient conditions.

    Product
    Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24, Software version 02.40. The RNS 9703 is intended for use by medical professionals to provide secondary cardiac and vital signs monitoring for multiple patients within a medical facility. The device w
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1979-2014·2014-07-09

    Nihon Kohden CNS-6201 Central Nurse Station Software Recall

    Nihon Kohden is recalling CNS-6201 Central Nurse Stations with software version 02-26 due to unexpected reboots that interrupt patient data display and alarms.

    Product
    CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
    Category
    Medical Device
    Distribution
    1 state

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Nihon Kohden

Tokyo-based leading developer and distributor of medical electronic equipment

Country
Japan
Founded
1951

Official website

Source: Wikidata (Q11507280), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.