Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ellex I.Science iTRACK 250A Recalled by Ellex iScience, Inc. Due to Sterility failure found in one of the units...
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
ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Quantity: 90 units
Why Was This Recalled?
Sterility failure found in one of the units in the lot.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ellex iScience, Inc.
Ellex iScience, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report