Facility

FREUDENBERG MEDICAL, 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)	1000121130
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	2301 Centennial Blvd Jeffersonville, IN, US 47130
Registration status	Active · expires 2026
Parent company	Freudenberg Medical, LLC (owner-operator 9000550)
Brand names	RFA Cleaning Cap

Activity by year

Recalls (1)

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 IITerminated2022-02-21
Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

All facilities operated by Freudenberg 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. “FREUDENBERG MEDICAL, LLC (FEI 1000121130) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000121130-freudenberg-medical-llc/

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