medical Class III Updated 2019-10-30

Xintec Corp recalls OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: PA, VA
Lot/Code Info: Lot # 21144, Use by 08/10/2021
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →