FDA Medical Device Recalls (openFDA)
Bryan Medical Inc: Aeris Balloon Dilation Catheter
- Recall number
- Z-2148-2023
- Recalling firm
- Bryan Medical Inc
- Product
- Aeris Balloon Dilation Catheter
- Status
- Open, Classified
- Initiated
- 2023-05-16
- Posted
- 2023-07-17
- Terminated
- not on file
- Reason
- Devices were mislabeled.
- Root cause
- Error in labeling
- Action
- Customers were emailed a recall notification dated 5/16/2023 requesting the return of affected devices. Customers were asked to quarantine all affected devices, complete the attached Recall Notification Confirmation Form, and return the form to the individuals identified in the notice.
- Quantity
- 5 units
- Distribution
- US Nationwide distribution in the states of GA, NY, & PA.
- Lot, serial or model codes
- Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.
- 510(k) numbers
- ["K150951"]
- PMA numbers
- not on file
- Product code
- KTI
- Firm FEI
- 3005803389
- Firm city
- Cincinnati
- Firm state
- OH
- 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