FDA Device recall Z-2148-2023
Aeris Balloon Dilation Catheter
- FDA Device
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of Aeris Balloon Dilation Catheter by Bryan Medical, citing devices were mislabeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2148-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-16 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bryan Medical |
| Distribution | US |
Product
Aeris Balloon Dilation Catheter
Reason
Devices were mislabeled.
Identifiers
| code_info | Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2148-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.