FDAFDA · Food and drugs·Recall number Z-1510-2025
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Published April 9, 2025 · Recall initiated: March 4, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
product mix-up; Vascular stent labeled as one size but contains a different size.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cordis US Corp
- Distributor
- US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
- Lot
- Lot: 18298569/UDI: (01)20705032024591
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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