Leoni Fiber Optics GmbH: Medical Device Recall in 2018 - (Recall #: Z-0580-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-1000-RT 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.

Product Classification:

Class II

Date Initiated: October 17, 2018

Date Posted: December 19, 2018

Recall Number: Z-0580-2019

Event ID: 81519

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.

Status: Terminated

Product Quantity: N/A

Code Information:

096877 00816901020296

Distribution Pattern:

US Distribution to the state of: Ohio.

Voluntary or Mandated:

Voluntary: Firm initiated