Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Aeroneb Professional Nebulizer System is a portable medical device Recalled by Aerogen Ltd. Due to Aerogen has received a small number of complaints...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aerogen Ltd. directly.
Affected Products
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.
Quantity: 2,421 power adapters
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aerogen Ltd.
Aerogen Ltd. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report