Bryan Medical Inc: Medical Device Recall in 2023 - (Recall #: Z-2148-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Aeris Balloon Dilation Catheter

Product Classification:

Class II

Date Initiated: May 16, 2023

Date Posted: July 26, 2023

Recall Number: Z-2148-2023

Event ID: 92558

Reason for Recall:

Devices were mislabeled.

Status: Ongoing

Product Quantity: 5 units

Code Information:

Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.

Distribution Pattern:

US Nationwide distribution in the states of GA, NY, & PA.

Voluntary or Mandated:

Voluntary: Firm initiated