Facility

Freudenberg Medical, LLC

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

Key facts

1recalls · worst Class II

3inspections · 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)	3008581151
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	5050 Rivergrade Rd Baldwin Park, CA, US 91706
Registration status	Active · expires 2026
Parent company	Freudenberg Medical, LLC (owner-operator 2025182)

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Condenser, Heat And Moisture (Artificial Nose)
Product code BYD (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5375

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 (3)

NAI2025-02-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2022-03-01
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2016-09-19
Voluntary Action Indicated · Compliance: 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 3008581151) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008581151-freudenberg-medical-llc/

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