Facility

Mani Hanoi Co. Ltd Pho Yen 2 Factory

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)	3014276972
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Plot CN5, Diem Thuy Industrial Zone - Area A Thai Nguyen Province, VN -
Registration status	Active · expires 2026
Parent company	MANI, INC. (HEAD OFFICE) (owner-operator 8030343)
Brand names	MANI Sutures, Ophthalmic Sutures (with Needle); MANI Sutures Polyester

Activity by year

Recalls (2)

Devices registered here (2)

Suture, Nonabsorbable, Synthetic, Polyethylene
Product code GAT (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.5000
Needle, Suturing, Reusable
Product code GDL (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

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 Hanoi Co. Ltd Pho Yen 2 Factory (FEI 3014276972) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3014276972-mani-hanoi-co-ltd-pho-yen-2-factory/

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