iTRACK250A Canaloplasty Microcatheter Kit — Class II medical device recall Z-2590-2014
Terminated recall by Ellex iScience, Inc., reported 2014-09-10, distributed nationwide. One lot may not have been properly sealed, resulting in a non-sterile device.
| Recall number | Z-2590-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ellex iScience, Inc., Menlo Park, CA, United States |
| Recall initiated | 2014-08-06 |
| Classified | 2014-09-04 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2014-10-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, HK |
| Quantity | 148 devices |
| Reason classes | sterility |
| Lot numbers | 1404-03 |
| Model numbers | IT-250A |
| Expiration dates | 2016-03-31 |
Product
iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
Reason for recall
One lot may not have been properly sealed, resulting in a non-sterile device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2590-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.