Class II — Potential Health Hazard

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

iTRACK250A Canaloplasty Microcatheter Kit Recalled by Ellex iScience, Inc. Due to One lot may not have been properly sealed,...

Date: August 6, 2014
Company: Ellex iScience, Inc.
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 Ellex iScience, Inc. directly.

Affected Products

iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.

Quantity: 148 devices

Why Was This Recalled?

One lot may not have been properly sealed, resulting in a non-sterile device.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ellex iScience, Inc.

Ellex iScience, Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

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