Aeris Balloon Dilation Catheter (Bryan Medical) – Mislabeling (2023)
Mislabeling of medical devices may cause minor identification issues.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Aeris Balloon Dilation Catheter
Brand
Bryan Medical Inc
Lot Codes / Batch Numbers
Model No: KG0930, UDI: +B472KG09301, Lot No. 1402309E.
Products Sold
Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.
Bryan Medical Inc is recalling Aeris Balloon Dilation Catheter due to Devices were mislabeled.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices were mislabeled.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026