The Recall Desk
ModerateFDA (Devices)·Z-0120-2015·Announced 2014-10-29

Aerogen Nebulizer Power Adapter Recall Due to Broken Cover

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

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a broken cover on a power adapter, which presents a risk of electrical shock or injury, but the source text does not report any specific injuries or illnesses, fitting the Moderate criteria for a risk-of-harm product without reported injury.

Plain-English summary

Aerogen Ltd. is recalling 36 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 are supplied with specific Aeroneb Nebulizer systems, including Model Numbers 1079422, 1082693, and 1082694. The distribution of these products was worldwide, including the United States (nationwide) and numerous international locations such as Australia, Canada, China, and the United Kingdom.

Consumers should stop using the affected power adapters immediately. The source text does not specify a particular consumer action beyond the recall context, but users should contact Aerogen Ltd. for instructions on replacement or refund.

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 Accessories
Hazard
Affected units
36

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 (7)

  • FRIWO AC/DC Adapter Model Number: GPP10
  • Lot Numbers: 9070140620088
  • 9070140723088
  • 2) Model Number: 1082693
  • Lot Numbers: 9073140618134
  • 3) Model Number: 1082694
  • Lot Numbers: 9074140530079

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.

See all →

Same hazard · electrical shock

See all →