Aeris Balloon Dilation Catheter — Class II medical device recall Z-2148-2023
Ongoing recall by Bryan Medical Inc, reported 2023-07-26, distributed nationwide. Devices were mislabeled.
| Recall number | Z-2148-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bryan Medical Inc, Cincinnati, OH, United States |
| Recall initiated | 2023-05-16 |
| Classified | 2023-07-17 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 5 units |
| Reason classes | labeling |
| Lot numbers | 1402309E |
| Model numbers | KG0930 |
Product
Aeris Balloon Dilation Catheter
Reason for recall
Devices were mislabeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2148-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.