Leoni Fiber Optics recalls Laser Fiber Assemblies with Smartscope packaging due to risk of broken seals compromising sterility. Products may cause infection if used after seal breach. Affected units include specific model numbers sold in Smartscope packaging.
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 Fiber Optics is recalling Laser Fiber Assemblies sold in Smartscope packaging because some units have broken seals that could compromise sterility. Using these products after the seal breaks might increase infection risk during surgical procedures.
The packaging seal may break, compromising the sterile condition of the product. If the seal is broken, the device could become contaminated and increase infection risk during surgical procedures.
Surgical professionals using the Laser Fiber Assemblies in procedures like cutting or coagulating soft tissue. Patients undergoing surgery with these devices face the highest infection risk if the seal is broken.
Check for Smartscope single-box packaging with the model number SU-365-RT. Products sold with the private label 'SU-365-RT' in Smartscope packaging are affected.
Inspect the packaging seal for breaks or damage before use. If compromised, do not use the product.
The recall is due to reports of broken seals in Smartscope packaging that could compromise sterility, increasing infection risk during surgical procedures.
Check for Smartscope single-box packaging with the model number SU-365-RT. Products sold with the private label 'SU-365-RT' are affected.
Do not use the product if the seal is broken. Discard the item and contact Leoni Fiber Optics for further instructions.
We’ve drafted a message you can send Leoni Fiber Optics to request your refund or repair — edit it as you like.
Subject: Recall Z-0578-2019 — Leoni Fiber Optics Leoni Fiber Optics Hello, I own a Leoni Fiber Optics that is covered by recall Z-0578-2019 from Leoni Fiber Optics. 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.
