Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
1X1 Cleaving Tiles 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
1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.
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