Agency classClass IIOur severity:High FDA (Devices)·Z-2162-2015·Announced 2015-07-29

FDA Recalls Sure F!ex Reusable Lithotripsy Fibers Due to Sterilization Validation Issues

American Medical Systems is recalling 16,710 Sure F!ex reusable 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a High severity score (3) under the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 16,710 Sure F!ex 200µM Lithotripsy Fibers and associated reusable accessories. The recall is being conducted by American Medical Systems Innovation Center - Silicon Valley. The affected devices are intended for use in laser-based surgical applications, including endoscopic, laparoscopic, and open procedures involving tissue vaporization, ablation, and stone fragmentation.

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 new FDA guidance on qualifying reusable products. The affected units were manufactured between April 8, 2012, and April 8, 2015, and were distributed worldwide, including in the United States and numerous international markets.

Healthcare facilities and users of these devices should stop using the affected products and contact American Medical Systems for further instructions on the recall process.

The recalled product

Product: 200¿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…
Manufacturer: American Medical Systems Innovation Center - Silicon Valley
Category: Medical Device — Surgical Instruments
Hazard: infection
sterilization-failure
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 8013046
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

See all →

Moderate
FDA Recalls Disposable Fiber Strippers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
Moderate
FDA Recalls Fiber Cleaver Accessories Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
Moderate
FDA Recalls Fiber Cleavers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
High
FDA Recalls Disposable EndoStat Fiber Strippers Due to Validation Deficiencies
FDA (Devices) · 2015-07-29
Moderate
FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29

Same hazard · infection