Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sureflex 365 Lithotripsy Fiber Recalled by American Medical Systems Innovation Center - Silicon Valley Due to validation data related to cleaning instructions and sterilization...
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 American Medical Systems Innovation Center - Silicon Valley directly.
Affected Products
Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
Quantity: 16, 710 total all affected devices
Why Was This Recalled?
validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Medical Systems Innovation Center - Silicon Valley
American Medical Systems Innovation Center - Silicon Valley has 32 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report