Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SIROS D-Vial Prep Set Recalled by Sirtex Medical Limited Due to There is a potential presence of particulate matter...

Date: February 22, 2021
Company: Sirtex Medical Limited
Status: Terminated
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 Sirtex Medical Limited directly.

Affected Products

SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.

Quantity: 3310

Why Was This Recalled?

There is a potential presence of particulate matter in the D-Vial.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sirtex Medical Limited

Sirtex Medical Limited has 2 total recalls tracked by RecallDetector.

Related Recalls

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