RegWardenFDA facility compliance records
Facility

AEROGEN LTD

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

Activity by year

FDA actions on record by year2014: 1 recalls; 2018: 1 inspections1’14’15’16’171’18’19’20’21’22’23’24’25’26
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Nebulizer (Direct Patient Interface)
    Product code CAF (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…

FDA inspections (1)

  • NAI2018-05-11
    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.

Related

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 LTD (FEI 3003399703) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003399703-aerogen-ltd/

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