Z-2148-2023Class II

Aeris Balloon Dilation Catheter

Name: Z-2148-2023 Aeris Balloon Dilation Catheter
Creator: Bryan Medical Inc
Published: 2023-05-16
License: https://open.fda.gov/license/

Bryan Medical Inc / initiated 2023-05-16 / Open, Classified / root cause: labeling and UDI

FDA source

Bryan Medical Inc began a recall of Aeris Balloon Dilation Catheter on 2023-05-16. FDA classified it as Class II and gives the reason as "Devices were mislabeled". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2148-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-16
Posted: 2023-07-17
Recalling firm: Bryan Medical Inc
Product: Aeris Balloon Dilation Catheter
Product code: KTI Bronchoscope Accessory
Reason for recall: Devices were mislabeled.
Root cause tag: labeling and UDI
FDA 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 in commerce: 5 units
Distribution: US Nationwide distribution in the states of GA, NY, & PA.
Product codes and lots: Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2148-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2148-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-26	2023-07-17

Product code KTI

K150951Class IIaeris Balloon Dialation CatheterBryan Medical, Inc. / cleared 2015-06-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)