Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns
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 (infection risk due to compromised sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Leoni Fiber Optics GmbH is recalling specific single-use laser fiber assemblies intended for surgical procedures. The affected products are packaged in SmartScope single-box packaging and are distributed in the state of Ohio.
The recall is due to a potential broken package seal, which compromises the sterile integrity of the device. The source notes that two reports of compromised sterility have been received, and all products in this specific packaging are considered at risk. Using a device with a compromised seal could increase the risk of infection.
Consumers and healthcare providers should stop using the affected laser fibers and contact the recalling firm for further instructions.
The recalled product
- Product
- Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-Private label: SU-550-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulatin
- 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)
- 096876 00816901020289
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 Broken Seals
FDA (Devices) · 2018-12-19
- 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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