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    ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code JWM·February 10, 2003

    WECK AutoEndo5, Automatic Hem-O-Lok Clip Applier, REF AE05ML Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

    FDA Recall
    Open, Classified ·Teleflex Medical·Product code FZP·October 4, 2019

    WECK Hem-O-Lok AutoEndo5, 5mm Automatic Endoscopie Hem-o-lok Applier, REF 543965 Automatic Endoscopic Surgical Ligating Clip Appliers are delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips

    FDA Recall
    Open, Classified ·Teleflex Medical·Product code FZP·October 4, 2019

    Terumo Advanced Perfusion System 1 Base, 220/240V, Catalog 801764, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 16, 2012

    Terumo Advanced Perfusion System 1 Base, 100/120V, Catalog 801763, 6 " Roller Pump Occlusion: Reference AA-2011-015 C. Indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·March 16, 2012

    Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna.

    FDA Recall
    Terminated ·Synthes, Inc.·Product code HRS·January 7, 2014

    ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics·Product code GKZ·August 12, 2013

    Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LXH·January 18, 2010

    Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LXH·January 18, 2010

    Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code NQP·May 28, 2009

    Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LHX·January 18, 2010

    Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.

    FDA Recall
    Terminated ·Stryker Spine·Product code LXH·January 18, 2010

    Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.

    FDA Recall
    Terminated ·Illumina Inc·Product code PFF·July 28, 2014

    SurgAssist System Circular Stapler DLU 33mm

    FDA Recall
    Terminated ·Power Medical Interventions·Product code GWD·November 20, 2003

    SurgAssist System Circular Stapler DLU 29mm

    FDA Recall
    Terminated ·Power Medical Interventions·Product code GWD·November 20, 2003

    Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JEC·August 17, 2005

    Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·March 15, 2010

    Allen Medical C-Flex, Polar Head Positioner Catalog Number: A-70700-A1 Product is a medical device used to maintain the position of an anesthetized patient during surgery.

    FDA Recall
    Terminated ·Allen Medical Systems, Inc. One Post Office Square·Product code CCX·November 27, 2007

    Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086

    FDA Recall
    Terminated ·Intuitive Surgical, Inc.·Product code NAY·June 13, 2014

    Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only).

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTQ·November 10, 2006