FDA Device recall Z-1754-2025
BIB Balloon in Balloon Dilatation Catheter
- FDA Device
- Class II
- terminated
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of BIB Balloon in Balloon Dilatation Catheter by Numed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1754-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2025-04-21 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Numed |
| Distribution | PA |
Product
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
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.
Identifiers
| code_info | Model Number 420. UDI-DI: 04046964899768. Lot Numbers: BIB-16972 (Expiration date: 11/30/2028), BIB-16972-1 (Expiration…Model Number 420. UDI-DI: 04046964899768. Lot Numbers: BIB-16972 (Expiration date: 11/30/2028), BIB-16972-1 (Expiration date: 12/31/2028). Catheter Product Code: BB005. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1754-2025%22
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