Nihon Kohden America recalls

Nihon Kohden America has 10 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 13 Nov 2024. 6 are still ongoing. The most frequent reason is device malfunction.

Total recalls10since 2014

Last 12 months0reported

Class I00% of total

Ongoing6latest 13 Nov 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 3 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 10 100%Class III 0 0%

Why nihon kohden america is recalled

Device Malfunction660%
Other Reasons440%

Product types

By year

2024440%
2021220%
2017110%
2016110%
2015110%
2014110%

Ongoing nihon kohden america recalls

6 active

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS II	Adult Cap-ONE Biteblock recalled by Nihon Kohden America	Nihon Kohden America	Other	Nationwide
6 Nov 2024Device	CLASS II	Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 9m recalled	Nihon Kohden America	Device Malfunction	29 states
6 Nov 2024Device	CLASS II	Nihon Kohden Adult Ear Clip SpO2 Sensor, 5 meter recalled	Nihon Kohden America	Device Malfunction	29 states
12 Jun 2024Device	CLASS II	BSM-3000 Series Bedside Monitor recalled by Nihon Kohden America	Nihon Kohden America	Device Malfunction	Nationwide
10 Mar 2021Device	CLASS II	WMTS Telemetry Receiver, Multiple Patient Receiver recalled	Nihon Kohden America	Other	46 states
3 Feb 2021Device	CLASS II	PSG-1100 Sleep Diagnostic System recalled by Nihon Kohden America	Nihon Kohden America	Other	Nationwide

All nihon kohden america recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS II	Adult Cap-ONE Biteblock recalled by Nihon Kohden America	Nihon Kohden America	Other	Nationwide
6 Nov 2024Device	CLASS II	Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 9m recalled	Nihon Kohden America	Device Malfunction	29 states
6 Nov 2024Device	CLASS II	Nihon Kohden Adult Ear Clip SpO2 Sensor, 5 meter recalled	Nihon Kohden America	Device Malfunction	29 states
12 Jun 2024Device	CLASS II	BSM-3000 Series Bedside Monitor recalled by Nihon Kohden America	Nihon Kohden America	Device Malfunction	Nationwide
10 Mar 2021Device	CLASS II	WMTS Telemetry Receiver, Multiple Patient Receiver recalled	Nihon Kohden America	Other	46 states
3 Feb 2021Device	CLASS II	PSG-1100 Sleep Diagnostic System recalled by Nihon Kohden America	Nihon Kohden America	Other	Nationwide
19 Apr 2017Device	CLASS II	Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA recalled	Nihon Kohden America	Other	Nationwide
24 Feb 2016Device	CLASS II	MEE-1000A Neuromaster recalled by Nihon Kohden America	Nihon Kohden America	Device Malfunction	Nationwide
6 May 2015Device	CLASS II	Remote Network Station recalled by Nihon Kohden America	Nihon Kohden America	Device Malfunction	20 states
9 Jul 2014Device	CLASS II	CNS-6200 Series Central Nurse Station and accessories recalled	Nihon Kohden America	Device Malfunction	OK

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.