Facility

NIPRO CORPORATION ODATE FACTORY

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

Key facts

7recalls · worst Class II

2inspections · worst VAI

—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)	3002807710
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	8-7, Hanukiyachi, Niida ODATE-SHI Akita, JP 01857
Registration status	Active · expires 2026
Parent company	NIPRO CORPORATION (owner-operator 8030375)

Activity by year

Recalls (7)
Inspections (2)

Devices registered here (1)

Fibrin Split Products
Product code GHH (opens in a new tab) · Class II · Hematology · 21 CFR 864.7320

Recalls & enforcement

Class IIOngoing2025-10-27
Screw may loosen or fallout of Hemodialysis system
Class IITerminated2017-12-19
There is a possibility of the heparin line is occluded.
Class IITerminated2015-08-13
Some 1 1/4" needles were packaged and labeled in the 1" blister package.
Class IITerminated2015-03-30
Blood foaming was found during evaluation of the product.
Class IIITerminated2014-04-01
Device has the potential to have torn wings.
Class IITerminated2013-05-04
There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.
Class IITerminated2012-07-27
Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.

FDA inspections (2)

NAI2024-04-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2018-07-05
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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. “NIPRO CORPORATION ODATE FACTORY (FEI 3002807710) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807710-nipro-corporation-odate-factory/

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