The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1862-2013·Announced 2013-08-07

Acclarent Recalls Inspira AIR Balloon Dilation System for Labeling Corrections

Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.

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 involves labeling corrections to add warnings and clarify instructions, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls.

Plain-English summary

Acclarent, Inc. is recalling the Inspira AIR Balloon Dilation System, size 8.5 x 24 mm, with a 12 cc syringe volume. The recall involves 625 units of the device, which is used for the dilation of the airway tree.

The recall is initiated to correct labeling for all sizes of the system. The corrections include adding additional language and warnings, as well as clarifying certain instructional steps. The affected units are identified by product code BC8524A and include all lots manufactured after March 1, 2011.

The recalled devices 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 instructions on how to proceed with the labeling correction.

The recalled product

Product
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Manufacturer
Acclarent, Inc.
Category
Medical Device — Airway Dilation
Hazard
Affected units
625

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: BC8524A
  • 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.

See all 7 products in this recall →

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