Leoni recalls Smartscope laser fiber assemblies with potential broken seals that could compromise sterility and increase infection risk. Affected items shipped in Smartscope single-box packaging may need replacement.
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.
Leoni is recalling Smartscope laser fiber assemblies that may have broken seals, which could compromise sterility and increase infection risk. This affects products shipped in Smartscope single-box packaging. If you have these items, stop using them immediately.
Broken seals in the Smartscope packaging compromise sterility, meaning the device may not be clean enough for surgery. This could lead to infections if the device is used without a properly sealed package.
Surgical professionals using these laser fiber assemblies for procedures like cutting or coagulating tissue are most at risk. Patients using these devices could face infection if the seal is broken.
Check for Smartscope single-box packaging with the product label 'Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT'.
Discontinue use of the recalled Smartscope laser fiber assemblies if you have them.
The recall is due to potential broken seals in Smartscope single-box packaging that could compromise sterility and increase infection risk during surgery.
Check for Smartscope single-box packaging with the product label 'Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT'.
Stop using the product immediately and contact Leoni Fiber Optics GmbH for further instructions.
We’ve drafted a message you can send Leoni Fiber Opt: Smartscope to request your refund or repair — edit it as you like.
Subject: Recall Z-0581-2019 — Leoni Fiber Opt: Smartscope Leoni Fiber Opt: Smartscope Hello, I own a Leoni Fiber Opt: Smartscope that is covered by recall Z-0581-2019 from Leoni Fiber Opt: Smartscope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
