CLASS II Device recall · Reported 29 Oct 2014 · FDA Enforcement Report

The Aeroneb Professional Nebulizer System is a portable recalled

Aerogen is recalling The Aeroneb Professional Nebulizer System is a portable medical device for multiple, distributed nationwide in the US. The recall was initiated on 2 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: 1079422; Lot Numbers: 9070140620088 , 9070140723088 , 9070140723088; 2) Model Number: 1082693; Lot Numbers: 9073140618134; 3) Model Number: 1082694; Lot Numbers: 9074140530079

Quantity recalled36 power adapters

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0120-2015
FDA event ID: 69236
Recalling firm: Aerogen, Galway
Classification: Class II
Status: Terminated
Recall initiated: 2 Sep 2014
FDA classified: 23 Oct 2014
Reported: 29 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Sep 2014	Recall initiated by company
23 Oct 2014	Classified by FDA	+51 days
29 Oct 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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 adapter prior to use.

Product as listed by the FDA

The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.

Where it was distributed

Worldwide Distribution-USA (nationwide) including the states of CA, GA, IL, MS, NC, and TX, and the countries of Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Nationwide California Georgia Illinois Mississippi North Carolina Texas

Questions about this recall

Is The Aeroneb Professional Nebulizer System is a portable medical device for multiple recalled?

Yes. Aerogen recalled The Aeroneb Professional Nebulizer System is a portable medical device for multiple on 2 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0120-2015.

Why was it recalled?

Which lots are affected?

FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: 1079422; Lot Numbers: 9070140620088 , 9070140723088 , 9070140723088; 2) Model Number: 1082693; Lot Numbers: 9073140618134; 3) Model Number: 1082694; Lot Numbers: 9074140530079

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Aerogen

All 4

Reported	Class	Recall	Company	Reason	Where
29 Oct 2014Device	CLASS II	The Aeroneb Professional Nebulizer System is a portable recalled	Aerogen	Other	Nationwide
29 Oct 2014Device	CLASS II	The Aeroneb Professional Nebulizer System is a portable recalled	Aerogen	Other	Nationwide
29 Oct 2014Device	CLASS II	The Aeroneb Professional Nebulizer System is a portable recalled	Aerogen	Other	Nationwide

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