Z-0581-2019Class II

Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber...

Name: Z-0581-2019 Laser Fiber Assy-Single Use-LFS-200-0.22NA-SMA905-Extension Sleeve Silver-Sterile ETO-ForTec Fiber...
Creator: Leoni Fiber Optics GmbH
Published: 2018-10-17
License: https://open.fda.gov/license/

Leoni Fiber Optics, Inc. / initiated 2018-10-17 / Terminated / root cause: packaging

FDA source

Leoni Fiber Optics GmbH began a recall of 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... on 2018-10-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0581-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-17
Posted: 2018-12-07
Terminated: 2020-04-10
Recalling firm: Leoni Fiber Optics, Inc.
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, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.
Product code: GEX Powered Laser Surgical Instrument
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: The firm, LEONI, notified its distributor of the product issue on 10/16/18 via phone call and a subsequent "URGENT: MEDICAL DEVICE RECALL" letter. The distributor was informed of the product issue, and asked to disseminate recall information to customers. Actions to be taken by the Customer/User: End users should discontinue usage of the product. Product should be immediately quarantined. The Distributor should complete the acknowledgement of receipt form, to arrange for replacement and or credit to their account. A Leoni Customer Service Representative shall contact you with a Return material Authorization. If a replacement order is needed please inform customer service at the time of RMA issuance. - Discontinue usage if packaging irregularities exist - Return RMA units to Leoni Fiber Optics Inc. - Inform Customer Service if replacement product is required. - Complete acknowledge form and return back to Leoni Fiber Optics Inc. Attention Roger West, LFOI Quality Manager, [email protected] If you have any questions, please contact Quality Manager at 757-258-4805 or Email: [email protected].
Distribution: US Distribution to the state of: Ohio.
Product codes and lots: 096975 00816901020326

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0581-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0577-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0578-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0579-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0580-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07
Z-0581-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-07

Product code GEX

K050738Class IIFt Fiber Optic Delivery SystemsFibertech GmbH / cleared 2005-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)