Class II — Numed Inc
| Recalling firm | NUMED, INC. |
|---|---|
| Registered facility | NUMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 |
| Quantity | 4 units |
| Distribution | US distribution to Pennsylvania. |
| Initiated | 2025-04-21 |
| Classified | 2025-05-13 |
| Terminated | 2025-12-17 |
| Recall number | Z-1754-2025 |
| 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 — Numed Inc (Z-1754-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96734/
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