Sureflex 150 Lithotripsy Fiber — Class II medical device recall Z-2156-2015
Terminated recall by American Medical Systems Innovation Center - Silicon Valley, reported 2015-07-29, distributed nationwide. validation data related to cleaning instructions and sterilization methods and the methods defined in instruct
| Recall number | Z-2156-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Medical Systems Innovation Center - Silicon Valley, San Jose, CA, United States |
| Recall initiated | 2015-05-28 |
| Classified | 2015-07-21 |
| Reported by FDA | 2015-07-29 |
| Terminated | 2016-01-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BO, BR, CA, CH, CL, CO, CR, DE, ES, FI, FR, GB, GR, GT, IE, IL, IN, IT, KR, LB, LK, MA, MY, NL, NO, NZ, PA, PE, PL, PT, QA, RO, SA, TH, TR, UY, ZA |
| Quantity | 13,710 units |
| Model numbers | R-LLF150TG |
Product
Sureflex 150 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).
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2156-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.