Class II — Xintec Corp
| Recalling firm | XINTEC CORPORATION DBA CONVERGENT LASER TECHNOLOGIES |
|---|---|
| Registered facility | XINTEC CORPORATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 4343 units |
| Distribution | Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka. |
| Initiated | 2017-06-23 |
| Classified | 2017-08-02 |
| Terminated | 2018-06-20 |
| Recall number | Z-2866-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Xintec Corp (Z-2866-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77653/
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