The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2172-2015·Announced 2015-07-29

FDA Recalls Fiber Stripper Tools Due to Cleaning Validation Issues

American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 does not report any illnesses, injuries, or hospitalizations. The hazard is related to compliance with cleaning and sterilization validation guidance rather than a confirmed high-risk pathogen or structural defect causing immediate harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Fiber Stripper tool, Model 80-10001-001, manufactured by American Medical Systems Innovation Center - Silicon Valley. The recall affects 16,710 units manufactured between April 8, 2012, and April 8, 2015. These tools are used to strip the protective jacket off the end of Endostat or SureFlex Fibers and do not come into direct contact with patients.

The recall was initiated because validation data related to cleaning instructions and sterilization methods for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new FDA guidance on qualifying reusable products. The affected devices were distributed worldwide, including in the United States and numerous other countries.

Healthcare facilities and users of these devices should stop using the affected Fiber Stripper tools and contact American Medical Systems for further instructions on the recall process.

The recalled product

Product
Tool, StripperW/BLD, 10S, Nonautoclavable; 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…
Manufacturer
American Medical Systems Innovation Center - Silicon Valley
Category
Medical Device — Surgical Instrument
Hazard

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 (4)

  • Model 80-10001-001
  • All product manufactured from April 8
  • 2012 to April 8
  • 2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 recalled by American Medical Systems Innovation Center - Silicon Valley under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

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