BEUDAMED
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    BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGI·August 26, 2020

    Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CGI·December 8, 2009

    ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic. Catalog Numbers & Description: CAI-XLL, Level L; CAI-XL1, Level 1; CAI-XL2, Level 2; CAI-XL3, Level 3; CAI-XL4, Multi-Pack; CAI-XLS, Sample Pack;

    FDA Recall
    Terminated ·Microgenics Corporation·Product code JJY·December 14, 2011

    AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.

    FDA Recall
    Terminated ·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009

    AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

    FDA Recall
    Terminated ·Airgas Puritan Medical Puritan Medical Unit·Product code CAN·August 6, 2009

    ZVU Functional GI Software, REF: ZVU-3

    FDA Recall
    Open, Classified ·Diversatek Healthcare·Product code FFX·July 25, 2023

    Multitom RAX with software version VF10

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code OWB·April 20, 2021

    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

    FDA Recall
    Open, Classified ·Product code PPB·January 7, 2026

    Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721

    FDA Recall
    Open, Classified ·Product code PPB·January 7, 2026

    Medical Gas Yoke Assembly. Airgas Portable 4-Cylinder Manifold Cart Model #AGI-2238. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

    FDA Recall
    Terminated ·Western a Scott Fetzer Company·Product code CAN·August 10, 2009

    Medical Gas Yoke Assembly. Airgas Portable 2-Cylinder Manifold Cart Model #AGI-2237. The device is a medical gas yoke assembly which is used to connect gas cylinder post valves to equipment used for anesthesia or respiratory therapy.

    FDA Recall
    Terminated ·Western a Scott Fetzer Company·Product code CAN·August 10, 2009

    Grasper/Retriever, Alligator Jaw 2.4 mm x 5 mm x 230 cm Catalog Number: 7208 Intended use: single use accessory devices used through the working channel of a GI endoscope

    FDA Recall
    Completed ·Shent USA, Inc.·Product code OCZ·January 12, 2021

    MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations.

    FDA Recall
    Terminated ·Microgenics Corporation·Product code JJY·October 20, 2014

    Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope

    FDA Recall
    Completed ·Shent USA, Inc.·Product code OCZ·January 12, 2021

    Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code ODC·May 12, 2026

    D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitoring respiratory parameters. D-fend and D-fend+ water traps are used with Compact gas module E-C(Ai)O(V)(X) and CardioCap/5 monitors. The Datex-Ohmeda S/5 Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patients respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The device is indicated for use by qualified medical personnel only.

    FDA Recall
    Terminated ·GE Healthcare·Product code CCL·April 24, 2015

    Insignia Plus Multiprogrammable Pacemaker, DDDR Model 1295

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

    Meridian Multiprogrammable Pacemaker, DDDR Model 1276

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

    Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1297

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DXY·May 6, 2003

    Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Tip Shape, CS-Extended H, REF 6778

    FDA Recall
    Terminated ·Guidant Corp-Cpi Division·Product code DQR·March 11, 2004