The Recall Desk
HighFDA (Devices)·Z-2187-2015·Announced 2015-07-29

FDA Recalls Disposable EndoStat Fiber Strippers Due to Validation Deficiencies

American Medical Systems is recalling 16,710 disposable fiber strippers because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

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. Per the rubric, FDA Class II recalls without specific reports of hospitalization or significant injury are typically scored as High (3), particularly when the hazard involves validation deficiencies rather than direct contamination or acute injury.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Stripper, 0.2mm Disposable EndoStat Fiber, manufactured by American Medical Systems Innovation Center - Silicon Valley. The recall affects 16,710 units of Model 0010-0755 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 the new FDA guidance on qualifying reusable products. Although the specific device recalled is a disposable tool that does not come into direct contact with the patient, the validation deficiencies pertain to the broader accessory system and reusable components.

Healthcare providers and facilities that have purchased these devices should stop using them and contact American Medical Systems for further instructions on return or disposal. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Stripper, 0.2mm 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, corresp
Manufacturer
American Medical Systems Innovation Center - Silicon Valley
Category
Medical Device — Surgical Accessories
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 0010-0755
  • 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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