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.
What this means for you
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,
- 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 →Related recalls
Same manufacturer · American Medical Systems Innovation Center - Silicon Valley
See all →- ModerateFDA Recalls Disposable Fiber Strippers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- ModerateFDA Recalls Fiber Cleaver Accessories Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- ModerateFDA Recalls Fiber Cleavers Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
- HighFDA Recalls Disposable EndoStat Fiber Strippers Due to Validation Deficiencies
FDA (Devices) · 2015-07-29
- ModerateFDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues
FDA (Devices) · 2015-07-29
Same hazard · sterilization failure
See all →- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22