The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2184-2015·Announced 2015-07-29

FDA Recalls American Medical Systems Fiber Strippers Due to Sterilization Validation Issues

American Medical Systems is recalling 16,710 disposable 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, but the source text indicates a documentation and validation issue regarding sterilization methods rather than a reported injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for 16,710 units of the Stripper, 0.6mm Disposable EndoStat Fiber, manufactured by American Medical Systems Innovation Center - Silicon Valley. The recall affects all product manufactured between April 8, 2012, and April 8, 2015, under model number 0010-0751. These devices were distributed worldwide, including in the United States and numerous other countries.

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 on the recall process.

The recalled product

Product
Stripper, 0.6mm 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 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 0010-0751
  • 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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