FDA Medical devices recall ·
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC… recall
- Recall number
- Z-1510-2025
- Date
- (initiated March 4, 2025)
- Company / brand
- Cordis US Corp
14201 Nw 60th Ave, Miami Lakes, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 20 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Why was it recalled?
product mix-up; Vascular stent labeled as one size but contains a different size.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 18298569/UDI: (01)20705032024591
Distribution
US Distribution to states of: AR, AZ, FL, NJ, TN; and OUS Foreign country of: Japan
States: Arkansas Arizona Florida New Jersey Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1510-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.