Facility

Nihon Vinyl Cord Corporation - Kodama Second Factory

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

Key facts

9recalls · worst Class II

—inspections in our data

—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)	3021736577
Establishment type	Manufacture Medical Device
Location	1404-1 Kodama, Kodama-machi Honjo-shi Saitama, JP 16185
Registration status	Active · expires 2026
Parent company	NIHON KOHDEN CORP. (owner-operator 8030227)
Brand names	BLUPRO Attachment Tape; BLUPRO Attachment Tape, YS-111P7; YS-111P7 (P263A)

Activity by year

Recalls (9)

Devices registered here (1)

Tape And Bandage, Adhesive
Product code KGX (opens in a new tab) · Class I · General Hospital · 21 CFR 880.5240

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.

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 Vinyl Cord Corporation - Kodama Second Factory (FEI 3021736577) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021736577-nihon-vinyl-cord-corporation-kodama-seco/

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