Facility

ETHICON, LLC

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

Key facts

3recalls · 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)	3007791599
Establishment type	Manufacture Medical Device
Location	475 C Street Guaynabo, PR, US 00969
Registration status	Active · expires 2026
Parent company	ETHICON, LLC (owner-operator 10029715)
Brand names	Coated VICRYL Plus Antibacterial (Polyglactin 910) Absorbable Suture

Activity by year

Recalls (3)

Devices registered here (1)

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 IIOngoing2025-08-15
Potential for barb non-engagement.
Class IIOngoing2024-10-08
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Class IIOngoing2023-08-10
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

All facilities operated by ETHICON, 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, LLC (FEI 3007791599) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007791599-ethicon-llc/

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