FDA Medical Device Recalls (openFDA)
Acclarent, Inc.: Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
- Recall number
- Z-1862-2013
- Recalling firm
- Acclarent, Inc.
- Product
- Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
- Status
- Terminated
- Initiated
- 2013-01-11
- Posted
- 2013-08-01
- Terminated
- 2013-10-25
- 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.
- Root cause
- Device Design
- Action
- Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
- Quantity
- 625
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
- Lot, serial or model codes
- Product code: BC8524A; All lots manufactured after March 1, 2011
- 510(k) numbers
- ["K090660","K110218"]
- PMA numbers
- not on file
- Product code
- KTI
- Firm FEI
- 3005172759
- Firm city
- Menlo Park
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28