Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Cordis ANGIOGRAPHIC CATHETERIZATION SETS Recalled by Cordis US Corp Due to Non-sterile product labeled as sterile was distributed.

Date: September 26, 2023
Company: Cordis US Corp
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cordis US Corp directly.

Affected Products

Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Quantity: 30 devices

Why Was This Recalled?

Non-sterile product labeled as sterile was distributed.

Where Was This Sold?

This product was distributed to 1 state: OK

Affected (1 state)Not affected

About Cordis US Corp

Cordis US Corp has 22 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report