Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2186-2015·Announced 2015-07-29

FDA Recalls American Medical Systems Fiber Strippers for Validation Issues

American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet new 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 involves validation data not meeting guidance for reusable products, which is a regulatory and quality control issue rather than a direct, reported injury or high-risk pathogen exposure, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

American Medical Systems Innovation Center - Silicon Valley is recalling 16,710 units of the Stripper, 0.3mm Disposable EndoStat Fiber. The recall affects Model 0010-0754 manufactured between April 8, 2012, and April 8, 2015. These devices are distributed worldwide, including in the United States and numerous international markets.

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 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.

Healthcare facilities and distributors should stop using the affected devices and contact American Medical Systems for further instructions regarding the recall.

The recalled product

Product: Stripper, 0.3mm Disposable EndoStat Fiber, 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 Instruments
Hazard: validation-deficiency
sterilization-issues
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 0010-0754
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 · validation deficiency