Nihon Kohden America Inc recalls
Every recall we track for Nihon Kohden America Inc — 6 in all, from 2020–2024 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Nihon Kohden America Inc peaked in 2024 (3); 6 since 2017.
All FDA recall records for Nihon Kohden America Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 1 | 0 | 0 | 1 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 1 | 2 | 3 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Nihon Kohden America Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Nihon Kohden America Inc recalls
5 shown- UnratedMedical device
Nihon Kohden America Inc recalls Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Nihon Kohden recalls adult ear clip SpO2 sensors without FDA approval for U.S. use. This device may not meet safety standards, but no specific action is required.
Nihon KohdenSep 18, 2024 - Lower riskMedical device
Nihon Kohden America Inc recalls BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to
Nihon Kohden recalls BSM-3000 Series Bedside Monitors with serial numbers 1613-1651 due to false "SpO2 Probe Failure" alarms. Affected units may display incorrect alerts.
Nihon KohdenApr 29, 2024 - Lower riskMedical device
Nihon Kohden America Inc recalls Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen,
Nihon Kohden recalls expired Adult Cap-ONE Biteblock models YG-227T due to distribution after expiration. These devices may not function safely during endoscopy procedures.
Nihon Koh: The record says 'Nihon Kohden America Inc' — so the brand display is 'Nihon Kohden' (shortened from the legal name, common in consumer contexts).Apr 29, 2022 - Lower riskMedical device
Nihon Kohden America Inc recalls WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI: ORG 9100A/ 00841983102554 ORG 9110A/
Nihon Kohden recalls specific WMTS Telemetry Receivers due to incorrect date stamps or no data transfer. Affected models include ORG 9100A, 9110A, and 9700A with specific serial numbers. Consumers should check their device details.
Nihon KohdenJan 8, 2021 - Use cautionMedical device
Nihon Kohden America Inc recalls PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI
Nihon Kohden recalls PSG-1100 Sleep Diagnostic Systems with specific serial numbers due to electrical safety non-conformance with IEC 60601-1 standards. Affected units may pose a risk of electrical shock during sleep studies.
Nihon KohdenDec 21, 2020
Nihon Kohden America Inc recall questions
How many recalls has Nihon Kohden America Inc had?
6 recalls from Nihon Kohden America Inc are on record with U.S. safety agencies, from 2020–2024.
What is the most recent Nihon Kohden America Inc recall?
Nihon Kohden America Inc recalls Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each, dated Sep 18, 2024. Every Nihon Kohden America Inc recall is listed on this page, newest first.
What should I do if I have a recalled Nihon Kohden America Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Nihon Kohden America Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.