BEUDAMED
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    REVACLEAR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KDI·March 27, 2024

    REFLEX CATHETER

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·March 10, 2025

    REFLEX CATHETER

    FDA Adverse Event
    Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code DQY·March 10, 2025

    Hollow Fiber Dialyzer, Model TORAYSULFONE BS-1.6, and BS-1.8

    FDA Recall
    Terminated ·Toray Marketing & Sales (America), Inc·Product code FJI·December 30, 2003

    Hollow Fiber Dialyzer, Model FILTRYZER BK-2.IU

    FDA Recall
    Terminated ·Toray Marketing & Sales (America), Inc·Product code FJI·December 30, 2003

    Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area

    FDA Recall
    Terminated ·Asahi Medical Co., Ltd·Product code FJI·October 12, 2006

    Hollow Fiber Dialyzer Model FILTRYZER B3-1.0A, B3 -1.3A, and B3-1.6a

    FDA Recall
    Terminated ·Toray Marketing & Sales (America), Inc·Product code FJI·December 30, 2003

    Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code FJI·February 26, 2016

    Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FJI·August 29, 2025

    Hollow Fiber Dialyzer Model FILTRYZER B1-1.3H

    FDA Recall
    Terminated ·Toray Marketing & Sales (America), Inc·Product code FJI·December 30, 2003

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code FJI·November 16, 2016

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code FJI·November 22, 2016

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code FJI·December 27, 2016

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code FJI·December 19, 2016

    F6 DIALYZER FINISHED ASSY (CASE)

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code FJI·October 31, 2016

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code FJI·November 16, 2016

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code FJI·November 7, 2016

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code FJI·November 7, 2016

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code FJI·December 27, 2016

    F4 DIALYZER PRODUCTION ASSY.

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code FJI·November 17, 2016