Ellex iScience, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0011-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 11, 2018

Date Posted: October 10, 2018

Recall Number: Z-0011-2019

Event ID: 80569

Reason for Recall:

Sterility failure found in one of the units in the lot.

Status: Terminated

Product Quantity: 90 units

Code Information:

Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108

Distribution Pattern:

Distribution US nationwide and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated