BEUDAMED
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    ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

    FDA Enforcement
    Class II ·Terminated·Reshape Medical Inc·November 16, 2016

    Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    Genesys Analytical Column, REF 01-05-0017 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only.

    FDA Recall
    Terminated ·Clark Laboratories, Inc. (dba, Trinity Biotech USA)·Product code GKA·November 1, 2018

    TVS LPA, Catalog #: DIL-059-00

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

    Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

    GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code JWH·August 1, 2017

    Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code DYB·May 2, 2018

    MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LTT·May 4, 2018

    Leica M525 F20 Surgical Microscope System

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code EPT·September 4, 2018

    PremierPro Aluminum Adjustable Walker

    FDA Recall
    Terminated ·SVS LLC·Product code ITJ·October 1, 2018

    Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

    FDA Recall
    Terminated ·Medtronic Navigation, Inc.·Product code LLZ·June 1, 2018

    1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05, b) DRC-001-06, c) DRC-001-15, 2) Centeze Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-002-02, b) DRC-002-05, c) DRC-002-06, d) DRC-002-08,

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code KGZ·May 2, 2018

    1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code DRE·May 2, 2018

    MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.

    FDA Recall
    Terminated ·Canadian Hospital Specialties·Product code FPD·December 1, 2018

    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code DYB·May 2, 2018

    Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear

    FDA Recall
    Terminated ·ICU Medical de Mexico, S.A. de C.V. Avenida Cuarzo 250 Ensenada Ejido Maneadero Mexico·Product code FMG·March 1, 2018

    6" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer.

    FDA Recall
    Terminated ·ICU Medical de Mexico, S.A. de C.V. Avenida Cuarzo 250 Ensenada Ejido Maneadero Mexico·Product code FMG·March 1, 2018