Facility

Freudenberg Medical, LLC

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

Key facts

1recalls · worst Class II

1inspections · 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)	2025182
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	1110 Mark Ave CARPINTERIA, CA, US 93013
Registration status	Active · expires 2026
Parent company	Freudenberg Medical, LLC (owner-operator 2025182)

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Tape And Bandage, Adhesive
Product code KGX (opens in a new tab) · Class I · General Hospital · 21 CFR 880.5240

Recalls & enforcement

Class IIOngoing2026-06-17
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.

FDA inspections (1)

NAI2016-07-22
No 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.

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 2025182) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2025182-freudenberg-medical-llc/

Not open yet

Alerts for Freudenberg Medical, 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.