Recall archive / FDA device enforcement
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only — FDA record Z-1510-2025
Reported ongoing
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 Mar 4, 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
- Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
- Reason
- product mix-up; Vascular stent labeled as one size but contains a different size.
- Classification
- Class II
- Recalling firm
- Cordis US Corp
- Quantity
- 20 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1510-2025
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 | Lot: 18298569/UDI: (01)20705032024591 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
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
- Apr 9, 2025
- Recall initiation date
- Mar 4, 2025
- Center classification date
- Apr 3, 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.