FDA Recalls Sure F!ex Laser Fibers Due to Cleaning Validation Issues
American Medical Systems is recalling 16,710 Sure F!ex laser fibers 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 does not report any illnesses, injuries, or hospitalizations. The hazard is related to validation data not meeting guidance, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 16,710 Sure F!ex laser fibers, including the 365M Lithotripsy Fiber, manufactured by American Medical Systems Innovation Center - Silicon Valley. The recall affects all products manufactured between April 8, 2012, and April 8, 2015, under Model 8013056.
The recall was initiated because validation data related to cleaning instructions and sterilization methods for the Sure F!ex Reusable Fibers and associated Reusable Stripper and Cleaver Accessories do not meet the FDA's new guidance on qualifying reusable products. These devices are intended for use in laser-based surgical applications, including endoscopic, laparoscopic, and open procedures involving tissue vaporization, ablation, and fragmentation of calculi.
The affected devices were distributed worldwide, including in the United States and numerous other countries such as Argentina, Australia, Brazil, Canada, and the United Kingdom. Healthcare facilities and users should stop using these devices and contact American Medical Systems for further instructions regarding the recall.
The recalled product
- Product
- 365¿M Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
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 8013056
- 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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