FDA Medical Device Recalls (openFDA)
American Medical Systems Innovation Center - Silicon Valley: 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, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
- Recall number
- Z-2158-2015
- Recalling firm
- American Medical Systems Innovation Center - Silicon Valley
- 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, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary).
- Status
- Terminated
- Initiated
- 2015-05-28
- Posted
- 2015-07-21
- Terminated
- 2016-01-19
- Reason
- validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products
- Root cause
- Reprocessing Controls
- Action
- Urgent Medical Device Field notification letters were sent on June 9, 2015. Translation for countries out of the US will be conducted. Communications are being coordinated by the Prostate Health QA Director. Urgent Medical Device Field notification Letters advised customers of the issue and list all affected products with name and model numbers. Any SureFlex Reuseable Fibers which have not been used but are in inventory and with the 3 year shelf life should be returned as per instructions enclosed. Any of the SureFlex devices in inventory that have been used should be discarded or returned. All Reuseable Stripper and Cleaver Accessories that have not been used should be returned. Used devices should be destroyed or returned. Questions to 1-408-456-3320. The Acknowledgement form should be completed and returned.
- Quantity
- ~16,710 all affected device
- Distribution
- Worldwide Distribution - US Nationwide in the countries of: Argentina France Morocco, South Africa, Australia, Germany, Netherlands, Spain, Austria, Greece, New Zealand, Sri Lanka, Belgium, Guatemala, Norway, Switzerland, Bolivia, India, Panama, Thailand, Brazil, Ireland, Peru, Turkey, Canada, Israel, Poland, United Kingdom, Chile, Italy, Portugal, United States, Colombia, Korea, Qatar, Uruguay, Costa Rica, Lebanon, Romania, Finland, Malaysia and Saudi Arabia.
- Lot, serial or model codes
- Model R-LLF273TG All product manufactured from April 8, 2012 to April 8, 2015
- 510(k) numbers
- ["K050108"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 2937094
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28