The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2158-2015·Announced 2015-07-29

FDA Recalls Sureflex 273 Lithotripsy Fibers Due to Cleaning Validation Issues

American Medical Systems is recalling Sureflex 273 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 non-compliant validation data for cleaning and sterilization, which fits the criteria for a moderate severity recall involving potential risks without reported harm.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the Sureflex 273 Lithotripsy Fiber, 5x, Blue (Model R-LLF273TG). The recall was initiated by American Medical Systems Innovation Center - Silicon Valley. The affected devices were manufactured between April 8, 2012, and April 8, 2015.

The recall is due to validation data related to cleaning instructions and sterilization methods that do not meet FDA guidance on qualifying reusable products. Specifically, the methods defined in the instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories were found to be non-compliant with new guidance.

Approximately 16,710 units are affected. The devices were distributed worldwide, including in the United States and numerous other countries. These laser fibers are intended for use in laser-based surgical applications, including endoscopic, laparoscopic, and open surgical procedures. Users should contact the manufacturer for further instructions on how to proceed.

The recalled product

Product
Sureflex 273 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
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-LLF273TG 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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