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    Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DPS·June 3, 2024

    TLC-2000 Therapeutic Medical Laser System

    FDA Recall
    Terminated ·Theralase Inc.·Product code NHN·September 26, 2019

    Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band.

    FDA Recall
    Terminated ·EM Innovations Inc·Product code MMK·April 3, 2006

    Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids.

    FDA Recall
    Terminated ·Enginivity LLC·Product code LGZ·March 23, 2009

    Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the thorax is the physicians choice of treatment. It is indicated for patients having difficulty with secretion clearance or the presence of atelectasis caused by mucus plugging.

    FDA Recall
    Terminated ·HILL-ROM MANUFACTURING, INC.·Product code BYI·September 15, 2017

    Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, McGaw Park, IL 60085 The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient''s blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument incluide a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities anbd automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code KDI·November 15, 2002

    2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·July 27, 2022

    ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code JJE·December 12, 2006

    ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; Temperature Controller Board Part #78560-109; distributed by Abbott Laboratories, Irving, TX.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code JJE·December 12, 2006

    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.

    FDA Recall
    Terminated ·Thoratec Switzerland GMBH Technoparkstrasse 1 Zurich Switzerland·Product code KFM·August 22, 2019

    AD 7 Patient table supplied with Allura Xper FD10 and Allura Xper FD10/10. Product is non-tilting but can be purchased with a tilt option.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXI·March 14, 2008

    Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

    FDA Recall
    Terminated ·Product code CBK·January 8, 2010

    CDI TM 101 Monitor, CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System, The CDI TM 101 Hematocrit/Oxygen Saturation Monitoring System is intended for use during cardiopulmonary bypass procedures where you need continuous monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·April 28, 2011

    Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 19, 2013

    VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·February 16, 2016

    REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.

    FDA Recall
    Terminated ·Meta C.G.M. Spa Via Modena 22-24 Correggio Italy·Product code EMI·April 26, 2021

    REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.

    FDA Recall
    Terminated ·Meta C.G.M. Spa Via Modena 22-24 Correggio Italy·Product code EMI·April 26, 2021

    REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.

    FDA Recall
    Terminated ·Meta C.G.M. Spa Via Modena 22-24 Correggio Italy·Product code EMI·April 26, 2021

    REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.

    FDA Recall
    Terminated ·Meta C.G.M. Spa Via Modena 22-24 Correggio Italy·Product code EMI·April 26, 2021

    Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01 Software Version: N/A Product Description: 6 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393

    FDA Recall
    Open, Classified ·Spacelabs Healthcare, Inc.·Product code MHX·September 5, 2025