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    Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured by Lumenis, Ltd, 13 Hayetzira Street, Yokneam Industrial Park, Yokneam, Israel 20692

    FDA Recall
    Terminated ·Lumenis Inc.·Product code GEX·April 8, 2005

    (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.

    FDA Recall
    Open, Classified ·LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel·Product code GEX·January 23, 2025

    Lumenis brand Atlas, Corium, Elite, Elite Ultra 532nm Laser Systems; Manufactured before November 4, 2003; Manufactured by Lumenis, Inc., 3959 West 1820 South, Salt Lake City, Utah 84104

    FDA Recall
    Terminated ·Lumenis Inc.·Product code GEX·February 1, 2006

    Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

    FDA Recall
    Terminated ·Lumenis Inc.·Product code GEX·August 29, 2006

    Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

    FDA Recall
    Terminated ·Lumenis 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel·Product code GCJ·July 30, 2015

    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

    FDA Recall
    Terminated ·Lumenis Ltd 13 Hayetzira St.,Yokneam Ind. Park Yokneam Israel·Product code GEX·November 17, 2015

    Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and Structural Abnormalities of the Retina and Choroid including: " Proliferative and Severe and Very Severe Non-Proliferative Diabetic Retinopathy " Macular Edema associated with Proliferative or Non-Proliferative Diabetic Retinopathy " Choroidal Neovascularization " Retinal Neovascularization associated with Retinal Occlusive Disease (Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion) " Macular Edema associated with Branch Retinal Vein Occlusion " Retinal Tears and Detachments And Anterior Segments as follows: " Iridotomy in Closed Angle Glaucoma " Trabeculoplasty in Open Angle Glaucoma

    FDA Recall
    Terminated ·Lumenis, Inc.·Product code HQF·August 15, 2014

    Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)

    FDA Recall
    Open, Classified ·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024

    Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm)

    FDA Recall
    Open, Classified ·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024

    Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)

    FDA Recall
    Open, Classified ·D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands·Product code HQC·January 15, 2024

    Endo Ocular Directional Laser Probe, Lumenis Inc. Salt Lake City, UT STERILE EO

    FDA Recall
    Terminated ·Lumenis, Inc.·Product code HQF·July 27, 2010

    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

    FDA Recall
    Terminated ·Lumenis Limited 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel·Product code GEX·March 25, 2015

    The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

    FDA Recall
    Terminated ·Lumenis Limited 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel·Product code GCJ·January 2, 2013

    Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.

    FDA Recall
    Terminated ·Lumenis, Inc.·Product code GEX·August 19, 2013

    Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH USA, Inc., 201 Lindbergh Avenue, Livermore, California 94551

    FDA Recall
    Terminated ·Lumenis Inc.·Product code GEX·February 9, 2006

    IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical

    FDA Recall
    Terminated ·Lumenis, Inc.·Product code ITX·October 14, 2021

    Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL.

    FDA Recall
    Terminated ·Lumenis, Inc.·Product code GEX·December 18, 2007

    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060601CD

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008

    Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070603CD

    FDA Recall
    Terminated ·Bard Peripheral Vascular Inc·Product code FGE·August 29, 2008

    The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. This process, referred to as AtherotomyQ3J, allows dilatation of the target lesion with less pressure. The device is provided in 6 mm, 10 mm, and 15 mm lengths. The working length is the distance between the radiopaque marker bands. The proximal catheter shaft of the Flextome Cutting Balloon Device is a hypotube. This hypotube contains the inflation lumen for the balloon. The distal shaft is made of flexible material and contains two lumens. One lumen is for balloon inflation, and the second lumen is a guidewire lumen. The distal shaft is coated with a hydrophilic coating. The guidewire lumen is colored green for greater visibility. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchanges. A needle with a luer port is included for flushing the wire lumen prior to the insertion of appropriate coronary guide wires. CLlPIT1M clips are provided to aid in handling of the catheter.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code MCX·December 7, 2005