Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 2,366 units distributed in the US, Belgium, Canada, and Saudi Arabia.
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 a labeling correction to clarify instructions and add warnings. Per the rubric, minor labeling errors and voluntary precautionary recalls are classified as Moderate (Score 2).
Plain-English summary
Acclarent, Inc. is recalling the Inspira AIR Balloon Dilation System, size 7 x 24 mm, with a syringe volume of 6-8 cc. The recall involves 2,366 units of the device, which is used for the dilation of the airway tree. The recall is limited to product code BC0724A, covering all lots manufactured after March 1, 2011.
The recall is a labeling correction intended to include additional language and warnings, as well as to clarify some instructional steps. The agency has classified this as a Class II recall.
The affected units were distributed nationwide in the United States, as well as in Belgium, Canada, and Saudi Arabia. Users of the device should contact Acclarent, Inc. for further instructions regarding the labeling correction.
The recalled product
- Product
- Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
- Manufacturer
- Acclarent, Inc.
- Category
- Medical Device — Airway Dilation
- Hazard
- Affected units
- 2,366
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 (3)
- Product code: BC0724A
- All lots manufactured after March 1
- 2011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Acclarent, Inc. 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.
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