Nihon Kohden America Inc
Complete recall history across all FDA and CPSC categories — 10 total recalls
Nihon Kohden America Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (10)
FDA medical device enforcement actions by Nihon Kohden America Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 18, 2024 | Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 8090... | Due to oximeters not having FDA market approval or clearance to distribute in... | Class II |
| Sep 18, 2024 | Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusabl... | Due to oximeters not having FDA market approval or clearance to distribute in... | Class II |
| Apr 29, 2024 | BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Seri... | Due to software issue the device may give false "SpO2 Probe Failure" alarm | Class II |
| Apr 29, 2022 | Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to s... | Due to products being shipped/distributed to customers after the products exp... | Class II |
| Jan 8, 2021 | WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG ... | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. | Class II |
| Dec 21, 2020 | PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No.... | Medical device non-conformance to electrical safety standard (IEC 60601-1). | Class II |
| Mar 13, 2017 | Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Proble... | The Pause function on central monitors will not automatically resume when con... | Class II |
| Apr 14, 2015 | Remote Network Station, Catalog RNS-9703, Model No. RNS-9703-19, RNS-9703-24,... | Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703... | Class II |
| Jun 3, 2014 | CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201... | Software Version 02-26, when used with the Central Nursing Station (CNS) 6201... | Class II |
| Jan 19, 2012 | MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation),... | The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas ar... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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