The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0118-2015·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.

The agency’s classification

FDA (Devices): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, and the source text describes a physical defect (broken cover) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or defects without reported harm.

Plain-English summary

Aerogen Ltd. is recalling 2,421 FRIWO AC/DC power adapters (Model GPP10) used in the Aeroneb Solo and Pro Nebulizer systems. The recall is due to 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) and in numerous international markets such as Australia, Canada, China, and the United Kingdom. The adapters are components of the Aeroneb Professional and Solo Nebulizer Systems, which are portable medical devices intended to aerosolize physician-prescribed solutions for inhalation in adult and pediatric patients.

Consumers should stop using the affected power adapters and contact Aerogen for instructions on how to proceed. The recall is limited to the specific FRIWO AC/DC adapters identified in the source documentation.

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…
Manufacturer
Aerogen Ltd.
Category
Medical Device — Nebulizer Power Adapter
Hazard
Affected units
2,421

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: 8003140519057
  • 8003140708015
  • 8003140722089
  • 2) Model Number: AG-AP1040-EU
  • Lot Numbers: 800140731124
  • 8000140520074
  • 8000140520087
  • 8000140530103
  • 8000140619082
  • 8000140620092
  • 8000140624103
  • 8000140624118
  • 8000140701104
  • 8000140702153
  • 8000140721056
  • 8000140726097
  • 8000140728100
  • 8000140728117
  • 8000140728120

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 →

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