Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tool 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
Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size.
Quantity: 16,710 total 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