The Recall Desk

Manufacturer

Leoni Fiber Optics GmbH

5 recalls in our database name Leoni Fiber Optics GmbH as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
1
Most recent
2018-12-19

Of the 5 recalls from Leoni Fiber Optics GmbH we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • SevereFDA (Devices)·Z-0581-2019·2018-12-19

    Leoni Fiber Optics Recalls Sterile Laser Fibers Due to Broken Seals

    Leoni Fiber Optics is recalling sterile laser fiber assemblies distributed in Ohio because broken package seals may compromise sterility and increase infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber SU-200-TRUE-RT Label Smartscope packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coa
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0578-2019·2018-12-19

    Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Sterility Concerns

    Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging due to potential broken seals that compromise sterility.

    Product
    Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO- Private label: SU-365-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagula
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0579-2019·2018-12-19

    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.

    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
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0580-2019·2018-12-19

    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.

    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
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0577-2019·2018-12-19

    Leoni Fiber Optics Recalls Single-Use Laser Fibers Due to Broken Seals

    Leoni Fiber Optics is recalling single-use laser fibers in SmartScope packaging due to broken seals that compromise sterility and increase infection risk.

    Product
    Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coag
    Category
    Medical Device
    Distribution
    1 state