FDA Medical Device Recalls (openFDA)
Ellex iScience, Inc.: 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.
- Recall number
- Z-0011-2019
- Recalling firm
- Ellex iScience, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-01-11
- Posted
- not on file
- Terminated
- 2018-10-02
- Reason
- Sterility failure found in one of the units in the lot.
- Root cause
- Process control
- Action
- The recalling firm called their consignees on 1/11/2018 instructing them to quarantine unused devices and monitor the patients operated with the devices in this lot. The firm issued a letter dated 1/16/2018 via FedEx Express on 1/17/2018 informing them a potential issue had been identified and to segregate the product immediately.
- Quantity
- 90 units
- Distribution
- Distribution US nationwide and Switzerland.
- Lot, serial or model codes
- Lot 1711-08, Exp. 11/1/2019, UDI (01)00893872001059(17)191101(10)171108
- 510(k) numbers
- K080067
- PMA numbers
- not on file
- Product code
- HMX
- Firm FEI
- 3005641545
- Firm city
- Fremont
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28