Aerogen Ltd. 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 Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Aerogen Ltd.
Lot Codes / Batch Numbers
FRIWO AC/DC Adapter Model Number: GPP10, Lot Numbers: 9144140519057, 9144140616062, 9144140702155, 9144140710034, 2) Model Number: AG-AS3000-IN, Lot Numbers: 9125140522116, 9125140526101, 9125140527077, 9125140609002, 9125140609007, 9125140616064, 9125140627057, 9125140702166, 9125140710031, 9125140805010, 9125140805134, 3) Model Number: AG-AS3000-NE, Lot Numbers: 9122140520089, 9122140521089, 9122140528119, 9122140609041, 9122140626100, 9122140728097, 9122140730088, 4) Model Number: AG-AS3000-SC, Lot Numbers: 9124140609011, 9124140620092, 9124140623091, 5) Model Number: AG-AS3000-SE, Lot Numbers: 9123140521074, 9123140610023, 9123140710033, 9123140724097, 6) Model Number: AG-AS3000-UK, Lot Numbers: 9120140519028, 9120140519061, 9120140526111, 9120140630135, 9120140701144, 9120140702156, 9120140714044, 7) Model Number: AG-AS3000-US, Lot Numbers: 9121140521090, 9121140522091, 9121140522093, 9121140523094, 9121140613066, 9121140630138, 9121140707023, 9121140709030, 8) Model Number: AG-PX1000-IN, Lot Numbers: 9133140704002, 9) Model Number:, Lot Numbers:, 10) Model Number: AG-PX1000-NE, Lot Numbers: 9130140528119, 9130140616060, 9130140730040, 11) Model Number: AG-PX1000-SC, Lot Numbers: 9132140519072, 9132140526107, 12) Model Number: AG-PX1000-SE, Lot Numbers: 9131140623154, 13) Model Number: AG-PX1000-UK, Lot Numbers: 9128140519081, 9128140630135, 9128140709024, 14) Model Number: AG-PX1000-US, Lot Numbers: 9129140527093, 9129140617070, 9129140714047, 9129140721087, 15) Model Number: AG-PX1000-US-Promo, Lot Numbers: 9129140522090, 9129140522091, 9129140527093, 9129140528095, 9129140528096, 9129140616066, 9129140617067, 9129140617069, 9129140617070, 9129140617071
Products Sold
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: AG-AS3000-AU; Lot Numbers: 9144140519057 , 9144140616062 , 9144140702155 , 9144140710034; 2) Model Number: AG-AS3000-IN; Lot Numbers: 9125140522116 , 9125140526101 , 9125140527077 , 9125140609002 , 9125140609007 , 9125140616064 , 9125140627057 , 9125140702166 , 9125140710031 , 9125140805010 , 9125140805134; 3) Model Number: AG-AS3000-NE; Lot Numbers: 9122140520089 , 9122140521089 , 9122140528119 , 9122140609041 , 9122140626100 , 9122140728097 , 9122140730088; 4) Model Number: AG-AS3000-SC; Lot Numbers: 9124140609011 , 9124140620092 , 9124140623091; 5) Model Number: AG-AS3000-SE; Lot Numbers: 9123140521074 , 9123140610023 , 9123140710033 , 9123140724097; 6) Model Number: AG-AS3000-UK; Lot Numbers: 9120140519028 , 9120140519061 , 9120140526111 , 9120140630135 , 9120140701144 , 9120140702156 , 9120140714044; 7) Model Number: AG-AS3000-US; Lot Numbers: 9121140521090 , 9121140522091 , 9121140522093 , 9121140523094 , 9121140613066 , 9121140630138 , 9121140707023 , 9121140709030; 8) Model Number: AG-PX1000-IN; Lot Numbers: 9133140704002; 9) Model Number: ; Lot Numbers: ; 10) Model Number: AG-PX1000-NE; Lot Numbers: 9130140528119 , 9130140616060 , 9130140730040; 11) Model Number: AG-PX1000-SC; Lot Numbers: 9132140519072 , 9132140526107; 12) Model Number: AG-PX1000-SE; Lot Numbers: 9131140623154; 13) Model Number: AG-PX1000-UK; Lot Numbers: 9128140519081 , 9128140630135 , 9128140709024; 14) Model Number: AG-PX1000-US; Lot Numbers: 9129140527093 , 9129140617070 , 9129140714047 , 9129140721087; 15) Model Number: AG-PX1000-US-Promo; Lot Numbers: 9129140522090 , 9129140522091 , 9129140527093 , 9129140528095 , 9129140528096 , 9129140616066 , 9129140617067 , 9129140617069 , 9129140617070 , 9129140617071
Aerogen Ltd. is recalling The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that due to 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 Pr. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026