BEUDAMED
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    Cobas connection module (CCM) - OUTPUT UNIT The module CCM enables a unidirectional connection of the pre-analytical systems cobas p 612/ p 512 to analysis instruments from Roche Diagnostics, Hitachi or Sysmex by means of the Aloka transportation system

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code JQP·May 9, 2017

    Central Control Module for System 1: System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 22, 2012

    Central Control Module for System 1: System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 22, 2012

    Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802100. The Central Control Monitor (CCM) provides a centralized display of system information and on-screen control of all system devices. The CCM combines an embedded computer, a touchscreen, and a graphical user interface.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·January 12, 2009

    Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 21, 2012

    Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 21, 2012

    Datex-Ohmeda S/5 Critical Care Monitor with L-CICU01, L-CICU02A, L-ICU05 & L-ICUO5A software. CCM Indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinavregional perfusion, B ispectral index (BIS), and neurophysiological status of all hospital patients.

    FDA Recall
    Terminated ·GE Medical Systems Information Tecnology 9900 Inovation Drive RP 2122 3rd Floor Wauwatosa WI 53226·Product code MLD·February 6, 2006

    Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·June 8, 2021

    Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is intended for use by qualified medical personnel only.

    FDA Recall
    Terminated ·GE Medical Systems, LLC·Product code MSX·May 8, 2009

    AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product number 72402987. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Pump, 2 Cylinders.

    FDA Recall
    Terminated ·American Medical Systems·Product code JCW·February 9, 2007

    AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Tactile Pump, 2 Cylinders.

    FDA Recall
    Terminated ·American Medical Systems·Product code JCW·February 9, 2007

    CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx.

    FDA Recall
    Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

    CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx.

    FDA Recall
    Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

    CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx.

    FDA Recall
    Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

    CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA..

    FDA Recall
    Terminated ·CIVCO Medical Instruments Co., Inc.·Product code ITX·November 2, 2018

    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code DXZ·June 24, 2016

    2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code ERL·March 18, 2014

    progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.

    FDA Recall
    Terminated ·ProgenaCare·Product code KGN·April 18, 2022

    Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

    FDA Recall
    Terminated ·Product code LOX·August 20, 2003

    Endura No-React Dural Substitute 2 cm x 10 cm

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code DTZ·May 4, 2007