The Aeroneb Professional Nebulizer System is a portable medical… — Class II medical device recall Z-0121-2015
Terminated recall by Aerogen Ltd., reported 2014-10-29, distributed nationwide. Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO
| Recall number | Z-0121-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aerogen Ltd., Galway, Ireland |
| Recall initiated | 2014-09-02 |
| Classified | 2014-10-23 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2016-04-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, CH, CN, CZ, DE, DK, EG, FI, FR, GB, HU, IE, IL, IN, IT, KR, KW, MY, NL, NO, PL, QA, RU, SE, SG, TH, TR, VN |
| Quantity | 323 power |
| UPC / GTIN / UDI-DI | 09235140718022 |
| Lot numbers | 9235140718093, 9235140718154, 9263140718116, 9263140718137, 9263140730049, 9264140627057, 9264140627100, 9264140721112, 9264140724100, 9276140731046, 9277140721040 |
| Model numbers | AG-UC1000-NE, AG-UC1000-UK, AG-UC1500-NE, AG-UC1500-SC, AG-UC1500-SE, GPP10 |
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 adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0121-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.