Recall archive / FDA device enforcement
BIB Balloon in Balloon Dilatation Catheter. Model Number: 420 — FDA record Z-1754-2025
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 21, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Numed Inc
- Quantity
- 4 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-1754-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to Pennsylvania.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 21, 2025
- Recall initiation date
- Apr 21, 2025
- Center classification date
- May 13, 2025
- Termination date
- Dec 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.