FDAJune 23, 2017device
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, ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
xintec
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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