Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2160-2015·Announced 2015-07-29

FDA Recalls Sureflex 550 Lithotripsy Fibers Due to Sterilization Validation Issues

American Medical Systems is recalling Sureflex 550 Lithotripsy 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 the Sureflex 550 Lithotripsy Fiber, 5x, Blue (Model R-LLF550). The recall involves 16,710 devices manufactured between April 8, 2012, and April 8, 2015. These laser fibers are intended for use in surgical procedures involving the vaporization, ablation, and fragmentation of calculi and soft tissue.

The recall was initiated because validation data related to cleaning instructions and sterilization methods for the Sureflex Reusable Fibers and associated accessories do not meet FDA guidance on qualifying reusable products. The devices were distributed worldwide, including in the United States and numerous other countries.

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: Sureflex 550 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…
Manufacturer: American Medical Systems Innovation Center - Silicon Valley
Category: Medical Device — Surgical Instruments
Hazard: sterilization-failure
infection-risk
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 (3)

Model R-LLF550 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 →

Same manufacturer · American Medical Systems Innovation Center - Silicon Valley

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