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    CDLCAM, First-Pass Radionuclide Angiography Camera System, Model 70-500101, with operating Software Version B1A, marketed by CDL Medical Tech.

    FDA Recall
    Terminated ·GVI Technology Partners·Product code IYX·January 16, 2004

    PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use.

    FDA Recall
    Terminated ·Gsi Group Inc·Product code DSF·December 2, 2015

    Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.

    FDA Recall
    Terminated ·Covidien LLC dba Uni-Patch·Product code GXY·February 9, 2012

    Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.

    FDA Recall
    Terminated ·Covidien LLC dba Uni-Patch·Product code GXY·February 9, 2012

    Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

    FDA Recall
    Terminated ·Covidien LLC dba Uni-Patch·Product code GXY·February 9, 2012

    Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

    FDA Recall
    Terminated ·Covidien LLC dba Uni-Patch·Product code GXY·February 9, 2012

    Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.

    FDA Recall
    Terminated ·Mercedes Medical, Inc.·Product code QBD·June 10, 2021

    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

    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

    FDA Recall
    Terminated ·Pentax Medical Company·Product code KOG·July 17, 2014

    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

    Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.

    FDA Recall
    Terminated ·Fujifilm Medical Systems U.S.A., Inc.·Product code FDT·June 30, 2015