BIB Balloon in Balloon Dilatation Catheter — Class II medical device recall Z-1754-2025
Terminated recall by Numed Inc, reported 2025-05-21, distributed in PA. Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled
| Recall number | Z-1754-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Numed Inc, Hopkinton, NY, United States |
| Recall initiated | 2025-04-21 |
| Classified | 2025-05-13 |
| Reported by FDA | 2025-05-21 |
| Terminated | 2025-12-17 |
| Distributed | PA |
| Quantity | 4 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04046964899768 |
| Lot numbers | BIB-16972 |
| Model numbers | 420 |
| Expiration dates | 2028-11-30, 2028-12-31 |
Product
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Reason for recall
Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.
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-1754-2025. 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.