Facility

ETHICON ENDO-SURGERY, LLC

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)	3005075853
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	475 CALLE C GUAYNABO, PR, US 00969
Registration status	Active · expires 2026
Parent company	ETHICON ENDO-SURGERY, LLC (owner-operator 9071406)
Brand names	ENSEAL

Activity by year

Recalls (1)

Devices registered here (2)

Electrosurgical, Cutting & Coagulation & Accessories
Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400
Electrocautery, Gynecologic (And Accessories)
Product code HGI (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.4120

Recalls & enforcement

Class IIOngoing2025-03-07
Identified curing issues with the silicone during the needles manufacturing process.

All facilities operated by ETHICON ENDO-SURGERY, LLC

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. “ETHICON ENDO-SURGERY, LLC (FEI 3005075853) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005075853-ethicon-endo-surgery-llc/

Not open yet

Alerts for ETHICON ENDO-SURGERY, LLC

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.