Facility

SILEX MEDICAL, LLC

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

Key facts

1recalls · worst Class II

2inspections · worst VAI

—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)	3005110411
Establishment type	Manufacture Medical Device
Location	24 Robert Porter Rd Ste B SOUTHINGTON, CT, US 06489
Registration status	Active · expires 2026
Parent company	SILEX MEDICAL, LLC (owner-operator 9071595)
Brand names	SSI

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Electrosurgical, Cutting & Coagulation & Accessories
Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400

Recalls & enforcement

Class IIOngoing2024-01-09
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

FDA inspections (2)

VAI2025-04-23
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-06-11
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by SILEX MEDICAL, 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. “SILEX MEDICAL, LLC (FEI 3005110411) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005110411-silex-medical-llc/

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