Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2169-2015·Announced 2015-07-29

American Medical Systems Recalls Fiber Stripper Due to Sterilization Validation Issues

American Medical Systems is recalling Fiber Strippers 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. The hazard is a failure to meet validation guidance for sterilization, which is a regulatory and quality control issue rather than a reported injury or high-risk pathogen, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

American Medical Systems Innovation Center - Silicon Valley is recalling the Fiber Stripper, 910µm, Autoclavable. This tool is 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 recall affects 16,710 devices 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 Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new FDA guidance on qualifying reusable products. The devices were distributed worldwide, including in the United States and numerous other countries.

Users of these devices should stop using the affected Fiber Strippers and contact American Medical Systems for further instructions on the recall.

The recalled product

Product: Fiber Stripper, 910¿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: sterilization-failure
regulatory-non-compliance

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)

ModelS0-10008-003
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 →

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