The Recall Desk
HighFDA (Devices)·Z-0119-2015·Announced 2014-10-29

Aerogen Recalls FRIWO Power Adapters for Aeroneb Nebulizer Systems

Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device component with a physical defect (broken cover) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Aerogen Ltd. is recalling 1,223 FRIWO AC/DC power adapters (Model GPP10) used in the Aeroneb Solo and Pro Nebulizer systems. The recall was initiated after the company received a small number of complaints indicating that the power adapter cover had broken and dislodged from the body of the adapter prior to use.

The affected adapters were distributed worldwide, including in the United States (nationwide, with specific mentions of CA, GA, IL, MS, NC, and TX) and numerous international markets such as Australia, Canada, China, and the United Kingdom. The adapters are components supplied with various Aeroneb Professional and Solo Nebulizer System models, including AG-AS3000 and AG-PX1000 series units.

Consumers should stop using the affected power adapters immediately. Users can identify the affected units by checking the model number (GPP10) and cross-referencing the lot numbers provided in the official recall documentation. Aerogen is the recalling firm responsible for this action.

The recalled product

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 Professiona
Manufacturer
Aerogen Ltd.
Category
Medical Device — Nebulizer Power Adapter
Hazard
Affected units
1,223

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Aerogen Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Aerogen Ltd.

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Same hazard · physical defect

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