BEUDAMED
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    Instrument Manager driver : Driver sysu100i that connects to the Sysmex UF-100 analyzer Software all versions prior to( v7.00.0006 and v8.00.0005): v7.00.0001, v7.00.0002, v7.00.0003, v7.00.0004, v7.00.0005, v8 .00.0001, v8.00.0002, v8.00.0003, and v8 .00.0004

    FDA Recall
    Terminated ·Data Innovations, Inc.·Product code JQP·November 6, 2013

    Ventilator System Servo-i V3.1 Maquet Critical Care PC1771

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·May 23, 2006

    Astral 100, 150 Model: 27001, 27003 In the US, Astral devices are primarily used as non-invasive homecare devices, for example, the largest population of patients on the Astral device is COPD patients primarily using the device at night with some daytime use for recovery breathing. While it is possible that there may be scenarios where critically dependent patients may encounter this scenario, the likelihood of this leading to harm is negligible because critically dependent patients will have a form of backup ventilation as standard of care.

    FDA Recall
    Terminated ·Resmed Corporation·Product code CBK·January 13, 2016

    BD Vacutainer Specimen Collection Cups, Cat. No. 364975

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JTW·August 30, 2018

    KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JTW·August 30, 2018

    KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JTW·August 30, 2018

    BD Vacutainer Urine Collection Cups, Cat. No. 364941

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JTW·August 30, 2018

    SERVO Ventilator 300A (SV300A); Maquet Critical Care Ab, Solna, Sweden. The device is intended for general and critical ventilatory care of adult, pediatric, infant and neonatal patients. The unit is designed to be used at the bedside and for intra-hospital transport. It is not intended for transport use in ambulances or in helicopters in the US market.

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·December 19, 2008

    Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.

    FDA Recall
    Terminated ·Avid Medical, Inc.·Product code OKV·March 15, 2017

    Stryker Epic II Critical Care Bed, Model 2030/2031, Stryker Medical, Kalamazoo, MI. Critical Care Patient Bed.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNL·May 14, 2010

    Stryker Zoom Critical Care Bed, Model 2040. Stryker Medical, Kalamazoo, MI. Critical Care Patient Bed.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FNL·May 14, 2010

    Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·May 5, 2015

    Kion Anesthesia Workstation Maquet Critical Care AB SE-171-95 Solna, Sweden

    FDA Recall
    Terminated ·MAQUET Inc.·Product code BSZ·July 10, 2007

    Ventilator System SERVO-i V3.1 PC1777 Maquet Critical Care

    FDA Recall
    Terminated ·MAQUET Inc.·Product code CBK·May 23, 2006

    Baxter Three-Way Large Bore Stopcock with Male Luer Slip; a sterile, nonpyrogenic fluid pathway; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 2C6202. Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FMG·October 28, 2010

    LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.

    FDA Recall
    Terminated ·Zoll Manufacturing Corp.·Product code MVK·September 12, 2017

    Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code JAA·April 25, 2013

    Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

    FDA Recall
    Terminated ·Hologic, Inc.·Product code JAA·April 25, 2013

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FRN·June 30, 2020

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FRN·June 30, 2020