Facility

COOK IRELAND LTD

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

Key facts

1recalls · 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)	3001845648
Establishment type	Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	O HALLORAN ROAD LIMERICK Limerick(County), IE 000
Registration status	Active · expires 2026
Parent company	COOK IRELAND LTD (owner-operator 9052427)

Activity by year

Recalls (1)

Devices registered here (1)

Stents, Drains And Dilators For The Biliary Ducts
Product code FGE (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5010

Recalls & enforcement

Class IITerminated2012-01-05
Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. A…

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. “COOK IRELAND LTD (FEI 3001845648) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001845648-cook-ireland-ltd/

Not open yet

Alerts for COOK IRELAND LTD

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.