Recall Z-1511-2025— Cordis US Corp

Name: FDA recall Z-1511-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-04

Class II · Ongoing

Class II FDA medical device recall by Cordis US Corp, initiated 2025-03-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only. Reason: product mix-up; Vascular stent labeled as one size but contains a different size..

Recalling firm: Cordis US Corp
Classification: Class II
Status: Ongoing
Initiated: 2025-03-04
Firm location: Miami Lakes, FL, United States

Product description

Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only

Reason for recall

product mix-up; Vascular stent labeled as one size but contains a different size.

Data sourced from openFDA. This site is unofficial and independent of the FDA.