Leoni Fiber Optics recalls
Leoni Fiber Optics appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2018-12-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 5 |
|---|---|
| Published | 2018-12-19 |
| By agency | FDA Device (5) |
| By classification | Class II (5) |
| By status | terminated (5) |
| Distribution named in notices | OH |
Recalls
- Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging
FDA Device · Class II · 2018-12-19 · Leoni Fiber Optics
Reason: 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 p… - Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packagi…
FDA Device · Class II · 2018-12-19 · Leoni Fiber Optics
Reason: 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 p… - Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging
FDA Device · Class II · 2018-12-19 · Leoni Fiber Optics
Reason: 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 p… - Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging
FDA Device · Class II · 2018-12-19 · Leoni Fiber Optics
Reason: 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 p… - Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT SmartScope Packaging
FDA Device · Class II · 2018-12-19 · Leoni Fiber Optics
Reason: 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 p…