Facility

GORDIAN SURGICAL

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)	3011803381
Establishment type	Manufacture Medical Device
Location	17 Tchelet Street M.P. Misgav Northern, IL 20174
Registration status	Active · expires 2026
Parent company	Gordian surgical Ltd (owner-operator 10053542)
Brand names	TroClose 1200

Activity by year

Recalls (1)

Devices registered here (2)

Laparoscope, General & Plastic Surgery
Product code GCJ (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.1500
Suture, Absorbable, Synthetic, Polyglycolic Acid
Product code GAM (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4493

Recalls & enforcement

Class IITerminated2020-09-22
Endotoxin test results found above the acceptable levels in LAL test (above 20EU/device).

All facilities operated by Gordian surgical Ltd

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. “GORDIAN SURGICAL (FEI 3011803381) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011803381-gordian-surgical/

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