Xintec OptiLITE Laser Surgery Products Recall: Reprocessing Instructions May Be Inadequate
Xintec Corp recalls OptiLITE laser surgery products (catalog numbers HTM1020F, HTM1040F, HTM1060F, HTM1010F) due to potential insufficient reprocessing instructions for cleaning and sterilization, which may not meet new standards.
Lower-risk recall
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.
Contact the company
What happened, in plain English
Xintec Corp is recalling specific OptiLITE laser surgery products because the reprocessing instructions might not provide enough detail for proper cleaning, disinfection, and sterilization. This could lead to devices not meeting new safety standards, potentially affecting patient safety during medical procedures. Read more at govinfonow.com/recall/73635-xintec-optilite-laser-surgery-products-recall-reprocessing-instructions-may-be.
Source Summary by GovInfoNow · govinfonow.com/recall/73635-xintec-optilite-laser-surgery-products-recall-reprocessing-instructions-may-be · Updated September 21, 2026 · FDA enforcement record: FDA #Z-2866-2017
Cite this page
“Xintec OptiLITE Laser Surgery Products Recall: Reprocessing Instructions May Be Inadequate.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73635-xintec-optilite-laser-surgery-products-recall-reprocessing-instructions-may-be. Based on FDA recall #Z-2866-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2866-2017%22&limit=1).
Why it’s dangerous
The reprocessing instructions for cleaning, disinfection, and sterilization may not be detailed enough to meet new safety standards. This could result in the devices not being properly sterilized, potentially leading to infections or other complications during medical procedures.
Who’s affected
Medical professionals using the OptiLITE laser products for urological procedures or soft tissue treatments are most at risk. Patients undergoing surgery with these devices could be affected if the reprocessing is inadequate.
How to tell if you have this one
Check for the catalog numbers HTM1020F, HTM1040F, HTM1060F, or HTM1010F on the OptiLITE laser surgery products. These products were manufactured by Convergent Laser Technologies and used in urological procedures and soft tissue treatments.
- Brand
Xintec Corp- Category
Medical device
What to do — step by step
Check Product Details
Look for the catalog numbers HTM1020F, HTM1040F, HTM1060F, or HTM1010F on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution- US (Nationwide) and countries of: Canada and Sri Lanka.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2866-2017 (June 23, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2866-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.