Recall Register

Food, drugs, devices › Firms

Nihon Kohden America Inc

FDA recalling firm · 9 enforcement events · 10 product records · 2012–2024 · CA

Nihon Kohden America Inc has 9 FDA enforcement events on this register (10 product records) between 2012 and 2024: 9 device; the busiest year was 2024 with 2.

0% of its events are Class I; the most common class is Class II (9). 5 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
18 Sep 2024Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/BoxDeviceClass II2Ongoing
29 Apr 2024BSM-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.DeviceClass II1Ongoing
29 Apr 2022Adult 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.DeviceClass II1Ongoing
8 Jan 2021WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/ 00841983102561 ORG 9700A/No UDIDeviceClass II1Ongoing
21 Dec 2020PSG-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 (EEG) and other bio-potential signals and to…DeviceClass II1Ongoing
13 Mar 2017Bedside 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).DeviceClass II1Terminated
14 Apr 2015Remote 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 will display physiological data from up to…DeviceClass II1Terminated
3 Jun 2014CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.DeviceClass II1Terminated
19 Jan 2012MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)DeviceClass II1Terminated

By type and class

Device9
Class II9

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Nihon Kohden America Inc by year initiated.

Questions and answers

How many FDA recalls has Nihon Kohden America Inc had?

9 enforcement events (10 product records) on this register, 2012–2024: 9 device.

Are any Nihon Kohden America Inc recalls ongoing?

5 events are listed as ongoing in the current openFDA export.

What class are Nihon Kohden America Inc recalls?

9 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.