High FDA (Devices)·Z-2177-2015·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.

What this means for you

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 typically corresponds to a High severity score (3) when no specific hospitalizations or severe injuries are reported in the source text, but the defect involves sterilization validation for reusable medical devices.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Fiber Stripper tool, Model 80-10003-002, 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 new FDA guidance on qualifying reusable products. The agency classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

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, Mexico, and the United Kingdom. Healthcare facilities and distributors should stop using the affected Fiber Stripper tools and contact American Medical Systems for instructions on return or replacement.

The recalled product

Product: Tool, Stripper W/BLD, 14S, 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, correspond
Manufacturer: American Medical Systems Innovation Center - Silicon Valley
Category: Medical Device — Surgical Instrument
Hazard: sterilization-failure
infection-risk
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 80-10003-002
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 →

Same manufacturer · American Medical Systems Innovation Center - Silicon Valley

See all →

Moderate
FDA Recalls Disposable Fiber Strippers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
Moderate
FDA Recalls Fiber Cleaver Accessories Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
Moderate
FDA Recalls Fiber Cleavers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
High
FDA Recalls Disposable EndoStat Fiber Strippers Due to Validation Deficiencies
FDA (Devices) · 2015-07-29
Moderate
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29

Same hazard · sterilization failure