BEUDAMED
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    Hitachi HI VISION 6500, Model #EUB-6500, Ultrasound Diagnostic Scanner Device, Software Version V04-04 DICOM ServicePack 1 and EZU-FC5W.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code ITX·May 7, 2004

    DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order.

    FDA Recall
    Terminated ·DeVilbiss Healthcare LLC·Product code JCX·March 7, 2013

    EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code ITX·May 12, 2008

    EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code ITX·May 12, 2008

    Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN KIT, REF DYKM1184; c) DENTAL CDS, REF CDS984010B; d) EGD KIT, REF DYK1253578F; e) EGD REG KIT, REF DYKE1830; f) ENDO KIT, REF DYKE1516A; g) ERCP REG KIT, REF DYKM2127; h) GI PACK, REF DYKE1898; i) KIT, PEG, REG, REF DYKM2128; j) KIT,1500CC, 50CS, REF DYKM2126; k) LITHOTOMY, REF DYNJ909937; l) MAJOR BASIC, REF DYNJ909703; m) MINOR GENERAL SURGERY, REF DYNJ909940; n) SUCTION SET UP KIT, REF DYKM1187A; o) TURNOVER KIT, REF DYKC1274A; p) TURNOVER KIT MKT STRAPS, REF DYKC1309A; q) U BAR, REF DYNJ902374K

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code LRO·March 22, 2024

    Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code QAU·May 22, 2023

    Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code QAU·May 22, 2023

    stryker Sage PrimaFit External Urine Management System for the Female Anatomy

    FDA Recall
    Open, Classified ·Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804·Product code NZU·October 23, 2023

    Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code QAU·October 31, 2024

    Hemospray Endoscopic Hemostat

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc.·Product code QAU·July 24, 2019

    Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.

    FDA Recall
    Open, Classified ·Wilson-Cook Medical Inc.·Product code QAU·August 29, 2024

    Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment

    FDA Recall
    Open, Classified ·Lacrimedics Inc·Product code LZU·January 17, 2022

    VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU.

    FDA Recall
    Terminated ·Lacrimedics Inc·Product code LZU·November 26, 2014

    OPAQUE Herrick Lacrimal Plugs, HP3, 0.3 mm, HP5, 0.5mm, HP7, 0.7.mm, STERILE, EO, Rx only, CE Dry eye treatment

    FDA Recall
    Open, Classified ·Lacrimedics Inc·Product code LZU·January 17, 2022

    HEMO-10 Hemospray Endoscopic Hemostat

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020

    HEMO-7 Hemospray Endoscopic Hemostat

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc.·Product code QAU·February 4, 2020

    OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)

    FDA Recall
    Terminated ·Oasis Medical Inc·Product code LZU·July 6, 2006

    The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains either a red or blue base. The red base is identified with SKU #915363224. The blue base is identified with SKU #915363225. The product is distributed by the Invacare Corporation.

    FDA Recall
    Terminated ·Tung Keng Enterprise Co., Ltd. No.1, Lane 160, Section 2, Tan-Fu Road Tai-Tzu Hsiang, Taichung County Taiwan·Product code INI·November 1, 2005

    The product is a mobile 3-wheeled electric scooter, model HMV 220. The product contains either a red or blue base. The red base is identified with SKU #9153641905. The blue base is identified with SKU #9153641906. The product is distributed by the Invacare Corporation.

    FDA Recall
    Terminated ·Tung Keng Enterprise Co., Ltd. No.1, Lane 160, Section 2, Tan-Fu Road Tai-Tzu Hsiang, Taichung County Taiwan·Product code INI·November 1, 2005