CLASS II Device recall · Reported 19 Dec 2018 · FDA Enforcement Report
Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extensi recalled
Leoni Fiber Optics is recalling Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile, distributed in Ohio. The recall was initiated on 17 Oct 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0580-2019
- FDA event ID
- 81519
- Recalling firm
- Leoni Fiber Optics, Neuhaus-Schierschnitz, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Oct 2018
- FDA classified
- 7 Dec 2018
- Reported
- 19 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 17 Oct 2018 | Recall initiated by company | |
| 7 Dec 2018 | Classified by FDA | +51 days |
| 19 Dec 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to the state of: Ohio.
Questions about this recall
Is Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile recalled?
Yes. Leoni Fiber Optics recalled Laser Fiber Assy-Single Use-LFS-940-RT-0.22NA-SMA905-Extension Sleeve Silver-Sterile on 17 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0580-2019.
Why was it recalled?
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.
Which lots are affected?
096877 00816901020296
Where was it sold?
US Distribution to the state of: Ohio.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Leoni Fiber Optics
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Laser Fiber Assy-Single Use-LFS-550-RT-0.22NA-SMA905-Extensi recalled | Leoni Fiber Optics | Sterility | OH |
| Device | CLASS II | Laser Fiber Assy-Single Use-LFS-365-RT-0.22NA-SMA905-Extensi recalled | Leoni Fiber Optics | Sterility | OH |
| Device | CLASS II | Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim recalled | Leoni Fiber Optics | Sterility | OH |
| Device | CLASS II | Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension recalled | Leoni Fiber Optics | Sterility | OH |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |