FDA Recalls Sureflex 365 Lithotripsy Fibers Due to Sterilization Validation Issues
American Medical Systems is recalling 16,710 Sureflex 365 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. The hazard involves a failure to meet validation guidance for sterilization, which is a significant quality issue, but the source text does not report any specific illnesses, injuries, or hospitalizations, placing it in the Moderate category rather than High or Severe.
Plain-English summary
American Medical Systems Innovation Center - Silicon Valley is recalling 16,710 units of the Sureflex 365 Lithotripsy Fiber, 5x, Blue (Model R-LLF365). The affected devices were manufactured between April 8, 2012, and April 8, 2015, and were distributed worldwide, including in the United States and numerous other countries.
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 the new FDA guidance on qualifying reusable products. The devices are intended for use in laser-based surgical applications, including endoscopic, laparoscopic, and open procedures involving tissue vaporization, ablation, and fragmentation of calculi.
Healthcare facilities and distributors should stop using the affected devices and contact the recalling firm for further instructions. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- Sureflex 365 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-LLF365 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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