The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2176-2015·Announced 2015-07-29

FDA Recalls American Medical Systems Fiber Stripper Tools Due to Sterilization Issues

American Medical Systems is recalling Fiber Stripper tools because their cleaning and sterilization instructions do not meet FDA guidance for reusable medical devices.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves non-compliance with sterilization guidance for reusable medical devices, which poses a risk of infection or harm if the devices are not properly cleaned, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the American Medical Systems Fiber Stripper, a tool used to remove protective jackets from Endostat or SureFlex Fibers. The recall affects 16,710 units of the Tool, Stripper W/BLD, 14S, Nonautoclavable (Model 80-10003-001) manufactured between April 8, 2012, and April 8, 2015.

The recall was initiated because the validation data related to cleaning instructions and sterilization methods for these reusable accessories do not meet the FDA's new guidance on qualifying reusable products. The Fiber Stripper is designed to be used with Sureflex Reusable Fibers and does not come into direct contact with the patient.

The affected devices were distributed worldwide, including in the United States and numerous international markets such as Canada, the United Kingdom, Germany, and Australia. Users of these devices should contact American Medical Systems Innovation Center - Silicon Valley for further instructions on how to proceed with the recall.

The recalled product

Product
Tool, Stripper W/BLD, 14S, 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
Affected units
16,710

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 80-10003-001
  • 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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