OptiLITE — Class II medical device recall Z-2866-2017
Terminated recall by Xintec Corp, reported 2017-08-09, distributed nationwide. It has been determined that the reprocessing instructions may not provide sufficiently detailed information fo
| Recall number | Z-2866-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xintec Corp, Alameda, CA, United States |
| Recall initiated | 2017-06-23 |
| Classified | 2017-08-02 |
| Reported by FDA | 2017-08-09 |
| Terminated | 2018-06-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, LK |
| Quantity | 4,343 units |
| Model numbers | HTM1010F, HTM1020F, HTM1040F, HTM1060F |
Product
OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is related to urology, but ultimately it is up to the surgeon except in cases where it is contraindicated. The fibers are usually used in cases involving stones anywhere from the bladder up to the kidneys. Occasionally the laser system is used in soft tissue cases (non-cancerous tumors) in and around the urinary system.
Reason for recall
It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards.
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-2866-2017. 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.