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.
What this means for you
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 does not report any illnesses, injuries, or hospitalizations. The hazard is related to compliance with sterilization validation guidance rather than a confirmed safety failure, fitting the criteria for a moderate severity voluntary or precautionary recall.
Plain-English summary
American Medical Systems Innovation Center - Silicon Valley is recalling the Fiber Stripper, 550µm, Autoclavable. This tool is used to strip the protective jacket off the end of an Endostat or SureFlex Fiber. The device does not come into direct contact with the patient. The recall involves 16,710 units of Model 80-10011-003 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 agency classified this as a Class II recall.
The affected devices were distributed worldwide, including in the United States and numerous other countries. Users should stop using the affected Fiber Strippers and contact the manufacturer for further instructions.
The recalled product
- Product
- Fiber Stripper, 550¿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
- 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 80-10011-003
- 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.
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