Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall
Acclarent is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 1,217 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 classified as FDA Class II and involves a labeling correction to add warnings and clarify instructions. This aligns with the rubric for moderate severity, as it addresses potential risks through documentation updates rather than a confirmed high-risk defect or injury.
Plain-English summary
Acclarent, Inc. is recalling the Inspira AIR Balloon Dilation System, size 12 x 40 mm, with a 12 cc syringe volume. The recall involves 1,217 units of the device, which is used for the dilation of the airway tree. The affected product code is BC1240A, and the recall includes all lots manufactured after March 1, 2011.
The recall was initiated to correct labeling for all sizes of the Inspira AIR Balloon Dilation System. The corrections include adding additional language and warnings, as well as clarifying some instructional steps. This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The affected units were distributed nationwide in the United States, as well as in Belgium, Canada, and Saudi Arabia. Healthcare providers and facilities that have received these devices should stop using them and contact Acclarent, Inc. for instructions on how to return or dispose of the product.
The recalled product
- Product
- Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Manufacturer
- Acclarent, Inc.
- Category
- Medical Device — Airway Dilation
- Hazard
- Affected units
- 1,217
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: BC1240A
- 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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