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    ACUSON Redwood 2.0 ultrasound systems, REF: 11503314

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·July 13, 2023

    VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·May 6, 2011

    Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·May 6, 2011

    INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code OWB·December 29, 2017

    Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code IXR·October 21, 2004

    Sterile, Drape, Headset, Lower, Part Number 888944-01.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 15, 2008

    Sterile, Drape, Headset, Upper, Part Number 888945-01.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 15, 2008

    INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code OWB·March 11, 2015

    Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper).

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 15, 2008

    GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MMP·August 15, 2008

    TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

    FDA Recall
    Terminated ·Cardiac Assist, Inc·Product code DWF·December 2, 2010

    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGA·February 25, 2013

    Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214

    FDA Recall
    Terminated ·Nova Biomedical Corporation·Product code CGA·February 25, 2013

    Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FII·February 20, 2004

    EZ Single Cytofunnel Brown, A78710004 Product Usage: The EZ Single Cytofunnel with Brown filter papter are intended for single use with the Thermo Scientific Cytospin.

    FDA Recall
    Terminated ·Richard-Allan Scientific Company·Product code IFB·June 4, 2018

    PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.

    FDA Recall
    Terminated ·Dako North America Inc.·Product code IDY·May 1, 2008

    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

    System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FII·December 14, 2004

    Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.

    FDA Recall
    Terminated ·Iris Diagnostics·Product code JJW·September 18, 2012

    IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

    FDA Recall
    Terminated ·Iris Diagnostics·Product code JJW·July 9, 2012