Class II — Acclarent, Inc.
| Recalling firm | ACCLARENT, INC. |
|---|---|
| Registered facility | ACCLARENT, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree. |
| Quantity | 2366 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia. |
| Initiated | 2013-01-11 |
| Classified | 2013-08-01 |
| Terminated | 2013-10-25 |
| Recall number | Z-1861-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Acclarent, Inc. (Z-1861-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64625/
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