The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2166-2015·Announced 2015-07-29

FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

American Medical Systems is recalling 16,710 Fiber Stripper tools because cleaning and sterilization validation data 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, and the hazard involves potential failure to properly sterilize reusable medical devices, which poses a risk of harm even though no specific injuries are reported in the text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Fiber Stripper, 273µm, Autoclavable, manufactured by American Medical Systems Innovation Center - Silicon Valley. The recall affects 16,710 devices, specifically Model 80-10003-003, manufactured between April 8, 2012, and April 8, 2015.

The recall was initiated because validation data related to cleaning instructions and sterilization methods for the Fiber Stripper and associated SureFlex Reusable Fibers do not meet new FDA guidance on qualifying reusable products. The Fiber Stripper is a tool used to strip the protective jacket off the end of an Endostat or SureFlex Fiber and does not come into direct contact with the patient.

The affected devices were distributed worldwide, including in the United States and numerous other countries such as Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Spain, Switzerland, United Kingdom, and others. Healthcare facilities and distributors should stop using the affected devices and contact the manufacturer for further instructions.

The recalled product

Product
Fiber Stripper, 273¿m, 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…
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 80-10003-003
  • 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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