FDA Device recall Z-1864-2013
Inspira AIR Balloon Dilation system
- FDA Device
- Class II
- terminated
- Published 2013-08-07
On 2013-08-07 the FDA classified a Class II recall of Inspira AIR Balloon Dilation system by Acclarent, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1864-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-11 |
| Published | 2013-08-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Acclarent |
| Distribution | US |
Product
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
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.
Identifiers
| code_info | Product code: BC1240A; All lots manufactured after March 1, 2011 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1864-2013%22
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