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    Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) Part Numbers: FLX-274-20

    FDA Recall
    Open, Classified ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·March 10, 2023

    Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Recall
    Terminated ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code JQP·April 7, 2020

    FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Recall
    Terminated ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·April 7, 2020

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    FDA Recall
    Open, Classified ·Remel, Inc·Product code LRG·February 12, 2025

    OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.

    FDA Recall
    Terminated ·Novapproach Spine LLC·Product code OVD·October 12, 2022

    LOM Disposable Surgical Gowns/Medical Gowns, Single-Use

    FDA Recall
    Open, Classified ·THREAD COUNSEL INC DBA LAWS OF MOTION·Product code FYA·September 17, 2020

    iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic devices: either pneumatically actuated Ventricular Assist Devices (VADs) for total circulatory support, or (i.e., non-simultaneously) an intra-aortic balloon (IAB) catheter for counter-pulsation therapy.

    FDA Recall
    Terminated ·Abiomed, Inc.·Product code DSQ·April 23, 2009

    HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distributed both as stand alone devices and as components of the LVAS Implant kit. Manufactured/Distributed by Thoratec Corporation, Pleasanton, CA The HeartMate II Left Ventricular Assist System (LVAS) consists of an implantable blood pump connected to an eternal system controller by a percutaneous lead. The external controller is powered bye either batteries or a power supply that connects to AC Main power. The device is intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is also for use in patients with New York Heart Association class IIIB or IV end-stage left ventricular

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·September 1, 2010

    HeartWare HVAD Pump Kit, REF MCS1705PU

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 29, 2022

    HeartWare HVAD Pump Kit, REF 1104

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 29, 2022

    HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·May 16, 2023

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Recall
    Open, Classified ·Thoratec Corp.·Product code DSQ·March 1, 2024

    Heartware HVAD Pump Implant accessories, Product (REF) Number 1153

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·April 3, 2020

    Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·February 26, 2021

    Medtronic HVAD Pump Implant Kits

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·August 6, 2021

    Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)

    FDA Recall
    Open, Classified ·Thoratec Corp.·Product code DSQ·October 22, 2021

    Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001 ,Thoratec Corporation, Pleasanton, CA. 94588

    FDA Recall
    Terminated ·Thoratec Corp·Product code DSQ·October 19, 2007

    EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was retrospectively reported.

    FDA Recall
    Terminated ·BERLIN HEART GMBH Wiesenweg 10 Berlin Germany·Product code DSQ·May 18, 2018

    HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.

    FDA Recall
    Terminated ·Thoratec Corporation·Product code DSQ·March 30, 2017

    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US HVAD DC Adapter Controller: Model Number: 1440 HVAD DATA CABLE 1575- MONITOR, Model Number: 1575 HVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DE HeartWare Patient Pack, Model Number: 1475 HeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUS HeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUS The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·February 26, 2021