The Recall Desk
ModerateFDA (Devices)·Z-1720-2015·Announced 2015-06-17

Roscoe Mini Neb Compressor User Manual Recall for Warning Updates

Compass Health Brands is recalling 219,353 Roscoe Mini Neb Compressor user manuals to add warnings about proper handling and storage to reduce power cord damage.

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 and involves a documentation update to prevent equipment damage (power cord wear), which aligns with the rubric for moderate severity involving minor labeling/documentation issues or low-risk contamination.

Plain-English summary

Compass Health Brands is recalling 219,353 user manuals for the Roscoe Mini Neb Compressor (models AG-MNEB and DS-NEB). The recall is necessary because the company identified the need to update the manuals with additional warning statements regarding the proper handling and storage of the nebulizer.

The updated warnings are intended to better inform end users of proper care when using and storing the device. The goal is to reduce user damage, specifically wear and tear, to the power cord. The affected manuals were distributed worldwide, including in the United States and various international countries.

Consumers with these manuals should check if they are affected by the recall. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inhaler therapy that converts liquid medicine into a fine mist that is easily inhaled.
Affected units
219,353

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 (1)

  • Models AG-MNEB and DS-NEB

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically: