FDA Recalls Sureflex 200 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling Sureflex 200 Lithotripsy Fibers because validation data for cleaning and sterilization methods does 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, which typically indicates a temporary or medically reversible adverse health consequence. The source text cites a failure to meet validation guidance for sterilization methods rather than reporting specific injuries or illnesses, aligning with a Moderate severity rating for a precautionary regulatory compliance issue.
Plain-English summary
American Medical Systems Innovation Center - Silicon Valley is recalling approximately 16,710 Sureflex 200 Lithotripsy Fiber, 5x, Blue devices. The recall affects Model R-LLF200TG units manufactured between April 8, 2012, and April 8, 2015. These laser fibers are intended for use in laser-based surgical applications, including endoscopic, laparoscopic, and open procedures involving tissue vaporization, ablation, and fragmentation of calculi.
The recall was initiated because validation data related to cleaning instructions and sterilization methods for the Sureflex Reusable Fibers and associated Reusable Stripper and Cleaver Accessories do not meet the new FDA guidance on qualifying reusable products. The devices were distributed worldwide, including in the United States and numerous other countries.
Healthcare facilities and users should stop using the affected devices and contact American Medical Systems for further instructions regarding the recall.
The recalled product
- Product
- Sureflex 200 Lithotripsy Fiber, 5x, Blue; 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 (3)
- Model R-LLF200TG 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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