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    X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.

    FDA Recall
    Terminated ·X-NAV Technologies, LLC·Product code PLV·February 23, 2016

    PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it provides.

    FDA Recall
    Terminated ·Precision Medical, Inc.·Product code BTM·March 5, 2010

    Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher

    FDA Recall
    Terminated ·Tecan US, Inc.·Product code JQW·July 23, 2018

    SLIDERPREP PLUS SLIDE PREPARATION CENTRIFUGE. Produce a monolayer of cells onto a glass slide from any fluid suspension.

    FDA Recall
    Terminated ·Separation Technology, Inc.·Product code IFB·March 13, 2013

    VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot suction/irrigation catheter

    FDA Recall
    Terminated ·Santanello Surgical LLC·Product code JOL·June 10, 2019

    Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803A

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DYB·November 17, 2006

    Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803P

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DYB·November 17, 2006

    Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DYB·November 17, 2006

    Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803M

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DYB·November 17, 2006

    Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301805M

    FDA Recall
    Terminated ·Biosense Webster, Inc.·Product code DYB·November 17, 2006

    Brand name: Olympus ImageManager Software, Versions 6.0 through 6.4.1 (excluding version 6.3.8) Common name: Medical image storage device. Class I, 510 (k) exempt. (NOTE: any ImageManager Software sold as a stand-alone system is not impacted by this software malfunction since no opportunity exists for any image cross-linking. It is a condition of the software malfunction that the observed image crosslink results from the collision of data files from two separate ImageManager computers.)

    FDA Recall
    Terminated ·Olympus America Inc. Two·Product code LMB·August 19, 2003

    XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·November 25, 2013

    XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code MUJ·August 31, 2015

    Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI. The TOM bone mill is designed to grind any type of cortical or cancellous bone.

    FDA Recall
    Terminated ·Stryker Craniomaxillofacial Division·Product code LXH·February 18, 2010

    Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.

    FDA Recall
    Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·September 27, 2007

    DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.

    FDA Recall
    Terminated ·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code NBH·April 15, 2013