Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OptiLITE(TM) Products for Laser Surgery Recalled by Xintec Corp Due to It has been determined that the reprocessing instructions...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Xintec Corp directly.
Affected Products
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
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Xintec Corp
Xintec Corp has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report