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    LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code HRM·May 25, 2017

    Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea.

    FDA Recall
    Terminated ·Alcon Research Laboratories Ltd. Aspex Facility·Product code HRM·July 17, 2018

    LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that integrates an AC power module and microscope controls (Primary Control Panel and connectivity of foot controllers)

    FDA Recall
    Terminated ·Alcon Research, Ltd.·Product code HRM·August 11, 2015

    PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code HRM·September 25, 2017

    Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines with vertical direction of view

    FDA Recall
    Open, Classified ·Haag-Streit USA Inc·Product code HRM·November 20, 2020

    Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system

    FDA Recall
    Open, Classified ·Leica Microsystems, Inc.·Product code HRM·November 21, 2022

    Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code HRM·January 2, 2019

    RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

    FDA Recall
    Terminated ·Mako Surgical Corporation·Product code OLO·December 1, 2017

    Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis - Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis - As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis, where bone stock is of poor quality or inadequate for other reconstructive techniques as indicted by deficiencies of the femoral condyle/tibia plateau. These components are intended for implantation with bone cement. Stryker Orthopaedics; Howmedica Osteonics Copr. 325 Corporate Drive Mahwah, NJ 07430

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code HRY·November 25, 2008

    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023

    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023

    AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.

    FDA Recall
    Terminated ·Zoll Circulation, Inc.·Product code DRM·August 8, 2012

    AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR

    FDA Recall
    Open, Classified ·ZOLL Circulation, Inc.·Product code DRM·September 22, 2022

    Michigan Instruments Thumper Mechanical CPR Device; Model 1007.

    FDA Recall
    Terminated ·Michigan Instruments, Inc.·Product code DRM·August 4, 2006

    Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.

    FDA Recall
    Terminated ·Zoll Circulation, Inc.·Product code DRM·July 16, 2013

    LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

    FDA Recall
    Open, Classified ·Jolife AB Scheelevagen 17 Ideon Science Park Lund Sweden·Product code DRM·May 21, 2025

    LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part: "LUCAS 2 Chest Compression System***jolife***www.lucas-cpr.com***a product by JOLIFE***MANUFACTURER, MAIN OFFICE JOLIFE AB Scheelevagen 17 SE-223 70 LUND Sweden***www.jolife.com***". Designed to uninterrupted chest compressions at a consistent rate and depth.

    FDA Recall
    Terminated ·Jolife AB Ideon, Scheelev·Product code DRM·February 8, 2011

    Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

    FDA Recall
    Terminated ·Michigan Instruments, Inc.·Product code DRM·February 13, 2018

    RMU-2000 Automated Chest Compression Device

    FDA Recall
    Open, Classified ·Defibtech, LLC·Product code DRM·July 12, 2024

    Zoll Auto Pulse Resuscitation System; Zoll Circulation Inc., Sunnyvale, CA 94085 Cardiac Compressor used as an adjunct to manual CPR. Use of AutoPulse is intended to reduce the impact of rescuer fatigue and enable rescuer to address other patient needs.

    FDA Recall
    Terminated ·Zoll Circulation, Inc.·Product code DRM·January 28, 2008