Facility

MANI, INC. (TAKANEZAWA FACILITY)

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

Key facts

2recalls · 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)	1000550480
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	743 NAKAAKUTSU, TAKANEZAWA SHIOYA Tochigi, JP 32912
Registration status	Active · expires 2026
Parent company	MANI, INC. (HEAD OFFICE) (owner-operator 8030343)
Brand names	MANI SHORT BARBED BROACHES

Activity by year

Recalls (2)

Devices registered here (1)

Broach, Endodontic
Product code EKW (opens in a new tab) · Class I · Dental · 21 CFR 872.4565

Recalls & enforcement

Class IITerminated2023-02-20
A packaging defect may compromise the sterile barrier.
Class IITerminated2020-10-27
Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use

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. “MANI, INC. (TAKANEZAWA FACILITY) (FEI 1000550480) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000550480-mani-inc-takanezawa-facility/

Not open yet

Alerts for MANI, INC. (TAKANEZAWA FACILITY)

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.