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U.S. Department of Health and Human Services

Class 2 Device Recall Aeris Balloon Dilation Catheter

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  Class 2 Device Recall Aeris Balloon Dilation Catheter see related information
Date Initiated by Firm May 16, 2023
Date Posted July 17, 2023
Recall Status1 Open3, Classified
Recall Number Z-2148-2023
Recall Event ID 92558
510(K)Number K150951  
Product Classification Bronchoscope accessory - Product Code KTI
Product Aeris Balloon Dilation Catheter
Code Information Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.
Recalling Firm/
Bryan Medical Inc
6100 Wooster Pike
Cincinnati OH 45227-4209
For Additional Information Contact Sales
Manufacturer Reason
for Recall
Devices were mislabeled.
FDA Determined
Cause 2
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 in Commerce 5 units
Distribution US Nationwide distribution in the states of GA, NY, & PA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KTI and Original Applicant = Bryan Medical , Inc.