Numed Inc: Device Recall
Recall #Z-1754-2025 · 04/21/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1754-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Numed Inc
- Status
- Terminated
- Date Initiated
- 04/21/2025
- Location
- Hopkinton, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
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.
Product Description
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420
Distribution Pattern
US distribution to Pennsylvania.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.