Laser Fiber Assy-Single Use-LFS-200-0 — Class II medical device recall Z-0581-2019
Terminated recall by Leoni Fiber Optics GmbH, reported 2018-12-19, distributed in OH. A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thu
| Recall number | Z-0581-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leoni Fiber Optics GmbH, Neuhaus-Schierschnitz, N/A, Germany |
| Recall initiated | 2018-10-17 |
| Classified | 2018-12-07 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-04-10 |
| Distributed | OH |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00816901020326 |
Product
Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
Reason for recall
A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartscope single-box packaging are at risk of a compromised product seal. Broken seal pouches compromise sterility and could increase the risk of infection if used.
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-0581-2019. 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.