# FDA recall Z-2866-2017

> **Xintec Corp** · Class II · device recall initiated 2017-06-23.

## 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.

## Distribution

Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka.

## Key facts

- **Recall number:** Z-2866-2017
- **Recalling firm:** Xintec Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-23
- **Report date:** 2017-08-09
- **Termination date:** 2018-06-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Alameda, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2866-2017

## Citation

> AI Analytics. FDA recall Z-2866-2017. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2866-2017. Source: US FDA. Licensed CC0.

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