Cordis US Corp: Device Recall
Recall #Z-1510-2025 · 03/04/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1510-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Cordis US Corp
- Status
- Ongoing
- Date Initiated
- 03/04/2025
- Location
- Miami Lakes, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Reason for Recall
product mix-up; Vascular stent labeled as one size but contains a different size.
Product Description
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Distribution Pattern
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
Other Recalls by Cordis US Corp
- Class II: Risk 03/04/2025
- Class II: Risk 02/07/2025
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.