Fiber Cleaver — Class II medical device recall Z-2170-2015
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-2170-2015 |
|---|---|
| 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 | 16,710 all |
| Model numbers | 0010-0760 |
Product
Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient.
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-2170-2015. 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.