Facility

Aerogen Shannon

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)	3018070843
Establishment type	Manufacture Medical Device
Location	Shannon Industrial Estate Co. Clare, IE V14HN40
Registration status	Active · expires 2026
Parent company	Aerogen Ltd. (owner-operator 10024694)
Brand names	Aerogen Pro-X1 Controller System; Aerogen Ltd

Activity by year

Recalls (1)

Devices registered here (1)

Ventilator-Compatible Nebulizer
Product code SFP (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5630

Recalls & enforcement

Class IITerminated2014-09-02
Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the…

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. “Aerogen Shannon (FEI 3018070843) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3018070843-aerogen-shannon/

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