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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

    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

    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

    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 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

    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

    Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.

    FDA Recall
    Terminated ·Michigan Instruments, Inc.·Product code DRM·September 14, 2006

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107, P108. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·December 1, 2009

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·December 1, 2009

    LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS, TELIGEN, and PUNCTUA, ENERGEN, and INCEPTA. The PUNCTUA, ENERGEN, and INCEPTA are not currently approved in the US The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time, there is only one (1) released version for each model number. The current version is 7.1. Both the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWS·October 12, 2011

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·March 23, 2009

    Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code LWP·March 16, 2007

    These models are not available in the US. Guidant CONTAK RENEWAL 4 (models H190, H195). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Cardiac resynchronization therapy defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac resynchronization therapies. Ventricular tachyarrhythmia therapy is for the treatment of ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms that are associated with sudden cardiac death (SCD). Cardiac resynchronization therapy is for the treatment of heart failure (HF) and uses biventricular electrical stimulation to synchronize ventricular contractions. Cardioversion/defibrillation therapies include a range of low-and high-energy shocks using either a biphasic or monophasic waveform

    FDA Recall
    Terminated ·Boston Scientific CRM Corp·Product code NIK·May 15, 2006