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[Recalled] Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only — product mix-up | FDA 2025-03-04

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductCordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Brand / manufacturerCordis US Corp
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1510-2025
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date04 March 2025
EAN / barcode18298569

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: product mix-up; Vascular stent labeled as one size but contains a different size.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Cordis US Corp

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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