FDA Medical Device Recalls (openFDA)
Leoni Fiber Optics GmbH: 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.
- Recall number
- Z-0581-2019
- Recalling firm
- Leoni Fiber Optics GmbH
- 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.
- Status
- Terminated
- Initiated
- 2018-10-17
- Posted
- not on file
- Terminated
- 2020-04-10
- Reason
- 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
- 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, Roger.West2@leoni.com If you have any questions, please contact Quality Manager at 757-258-4805 or Email: Roger.West2@leoni.com.
- Quantity
- not on file
- Distribution
- US Distribution to the state of: Ohio.
- Lot, serial or model codes
- 096975 00816901020326
- 510(k) numbers
- ["K050738"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 3005128587
- Firm city
- Neuhaus-Schierschnitz
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28