Facility

Nihon Kohden America Fulfillment Center

9 recall(s) on record — most severe on record: Class II.

Key facts

9recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3030154814
Establishment type	Repack or Relabel Medical Device
Location	20091 Ellipse, Suite 100 Foothill Ranch, CA, US 92610
Registration status	Active · expires 2026
Parent company	NIHON KOHDEN CORP. (owner-operator 8030227)
Brand names	TG-980P CO2 Sensor Kit with Smart Connector; TG-980P1 CO2 Sensor Kit with Smart Cable; TG-980P1 CO2 Sensor Kit; TG-980P1 CO2 Sensor Kit with Smart Connector; TG-980P CO2 Sensor Kit; TG-980P1; TG-980P CO2 Sensor Kit with Smart Cable; TG-980P

Activity by year

Recalls (9)
Inspections (1)

Devices registered here (1)

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Product code CCK (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.1400

Recalls & enforcement

Class IIOngoing2024-09-18
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Class IIOngoing2024-04-29
Due to software issue the device may give false "SpO2 Probe Failure" alarm
Class IIOngoing2022-04-29
Due to products being shipped/distributed to customers after the products expiration date had past.
Class IIOngoing2021-01-08
Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.
Class IIOngoing2020-12-21
Medical device non-conformance to electrical safety standard (IEC 60601-1).
Class IITerminated2017-03-13
The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.
Class IITerminated2015-04-14
Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound.
Class IITerminated2014-06-03
Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on th…
Class IITerminated2012-01-19
The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow.

FDA inspections (1)

NAI2026-01-13
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Nihon Kohden America Fulfillment Center (FEI 3030154814) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3030154814-nihon-kohden-america-fulfillment-center/

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