Class II — Bryan Medical Inc
| Recalling firm | Bryan Medical Inc. |
|---|---|
| Registered facility | BRYAN MEDICAL INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Devices were mislabeled. |
| Product | Aeris Balloon Dilation Catheter |
| Quantity | 5 units |
| Distribution | US Nationwide distribution in the states of GA, NY, & PA. |
| Initiated | 2023-05-16 |
| Classified | 2023-07-17 |
| Recall number | Z-2148-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bryan Medical Inc (Z-2148-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92558/
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