Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals
Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging because broken seals may compromise sterility, increasing infection risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury (infection) has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Leoni Fiber Optics GmbH is recalling single-use laser fiber assemblies (LFS-940-RT-0.22NA-SMA905) packaged in SmartScope single-box packaging. The recall is due to a potential broken package seal, which compromises the sterility of the device. These laser peripherals are intended for use in laser surgical procedures for cutting, coagulating, or vaporizing soft tissue.
The source text notes that a percentage of the products shipped in this specific packaging may exhibit a broken seal. Two reports of compromised sterility have been received, but all products in SmartScope single-box packaging are considered at risk. The distribution was limited to the state of Ohio.
Broken seal pouches compromise sterility and could increase the risk of infection if the device is used. Users should check their inventory for SmartScope single-box packaging and stop using any units with broken seals.
The recalled product
- Product
- 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, coagulati
- Manufacturer
- Leoni Fiber Optics GmbH
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 096877 00816901020296
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Leoni Fiber Optics GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Leoni Fiber Optics GmbH
See all →- HighLeoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns
FDA (Devices) · 2018-12-19
- HighLeoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns
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- HighLeoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals
FDA (Devices) · 2018-12-19
- SevereLeoni Fiber Optics Recalls Sterile Laser Fibers Due to Broken Seals
FDA (Devices) · 2018-12-19
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