OptiLITE — Class III medical device recall Z-0162-2020
Terminated recall by Xintec Corp, reported 2019-10-30, distributed in PA, VA. It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from th
| Recall number | Z-0162-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xintec Corp, Alameda, CA, United States |
| Recall initiated | 2017-10-29 |
| Classified | 2019-10-18 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2021-04-28 |
| Distributed | PA, VA |
| Quantity | 45 lasers |
| UPC / GTIN / UDI-DI | 00855430006036 |
| Lot numbers | 21144 |
| Model numbers | 800, CGH1080F |
| Expiration dates | 2021-08-10 |
Product
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
Reason for recall
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
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-0162-2020. 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.