Xintec OptiLITE Laser Surgery Fibers Recalled for Reprocessing Instruction Deficiencies
Xintec Corp is recalling OptiLITE laser surgery products because reprocessing instructions may not meet new standards for cleaning and sterilization.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states that the issue is related to reprocessing instructions and validation data standards rather than a direct defect causing harm. No illnesses or injuries are reported, and the hazard is procedural rather than a direct physical defect, fitting the 'Moderate' criteria for low-risk or procedural issues.
Plain-English summary
Xintec Corp is recalling OptiLITE(TM) Products for Laser Surgery, including catalog numbers HTM1020F, HTM1040F, HTM1060F, and HTM1010F. The recall involves 4,343 units that were distributed nationwide in the United States, as well as in Canada and Sri Lanka.
The recall was initiated because the reprocessing instructions for these devices may not provide sufficiently detailed information for cleaning, disinfection, and sterilization. A preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet newly enacted standards. These products are primarily used in urology procedures, such as treating stones from the bladder to the kidneys, and occasionally for soft tissue cases in the urinary system.
Healthcare providers and facilities that have these products should contact Xintec Corp for instructions on how to handle the recall. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- 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
- Manufacturer
- Xintec Corp
- Affected units
- 4,343
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all codes.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Xintec Corp
See all →- LowXintec OptiLITE Laser Fiber Assembly Recall Due to Programming Error
FDA (Devices) · 2019-10-30
Same hazard · inadequate reprocessing instructions
See all →- ModerateCook Medical Recalls LapSac Introducers Due to Inadequate Reprocessing Instructions
FDA (Devices) · 2017-06-14
- ModerateCook Medical Recalls Willscher Vas Reapproximator Sets Due to Reprocessing Instructions
FDA (Devices) · 2017-06-14