Facility

Freudenberg Medical Plastic & Metal Manufacturing (Shenzhen) Co., Ltd.

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)	3012268721
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	101 of Block 2, F1-3 of Block 2 F1 of Block 8 and F2 of Block 1, Beiguang Industrial Park, Shenzhen Guangdong, CN 51811
Registration status	Active · expires 2026
Parent company	Freudenberg Medical, LLC (owner-operator 2025182)

Activity by year

Recalls (1)

Devices registered here (1)

Stand, Infusion
Product code FOX (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6990

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.

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 Plastic & Metal Manufacturing (Shenzhen) Co., Ltd. (FEI 3012268721) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012268721-freudenberg-medical-plastic-metal-manufa/

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