Inspira AIR Balloon Dilation system — Class II medical device recall Z-1860-2013
Terminated recall by Acclarent, Inc., reported 2013-08-07, distributed nationwide. Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language an
| Recall number | Z-1860-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acclarent, Inc., Menlo Park, CA, United States |
| Recall initiated | 2013-01-11 |
| Classified | 2013-08-01 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2013-10-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, SA |
| Quantity | 1,920 |
| Reason classes | labeling |
Product
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1860-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.