Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
OptiLITE Recalled by Xintec Corp Due to It has been determined that a lot of...
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, 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
Quantity: 45 lasers
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 2 states: PA, VA
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