Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Inspira AIR Balloon Dilation system. Size 10 x 40 mm Recalled by Acclarent, Inc. Due to Labeling correction for all sizes of the Inspira...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Acclarent, Inc. directly.
Affected Products
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Quantity: 2703
Why Was This Recalled?
Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Acclarent, Inc.
Acclarent, Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report