ellex I — Class II medical device recall Z-0011-2019
Terminated recall by Ellex iScience, Inc., reported 2018-10-10, distributed nationwide. Sterility failure found in one of the units in the lot.
| Recall number | Z-0011-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ellex iScience, Inc., Fremont, CA, United States |
| Recall initiated | 2018-01-11 |
| Classified | 2018-10-01 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2018-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH |
| Quantity | 90 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00893872001059 |
| Lot numbers | 1711-08 |
| Model numbers | IT-250A |
| Expiration dates | 2019-11-01 |
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.
Reason for recall
Sterility failure found in one of the units in the lot.
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-0011-2019. 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.