Facility

Bracco Injeneering S.A.

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—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)	3004753774
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	AVENUE DE SEVELIN 46 LAUSANNE Vaud, CH 1004
Registration status	Active · expires 2026
Parent company	Bracco Injeneering (owner-operator 9066379)

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Pump, Infusion Or Syringe, Extra-Luminal
Product code FIH (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5820

Recalls & enforcement

Class IITerminated2018-11-12
Insufficient seal on the sterile barrier of the device, compromising the sterility of the device

FDA inspections (1)

NAI2017-02-01
No Action Indicated · Compliance: Devices

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 Bracco Injeneering

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. “Bracco Injeneering S.A. (FEI 3004753774) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004753774-bracco-injeneering-s-a/

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