BEUDAMED
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    Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and 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-BIO-65 - 1.3 m2 surface area, Model AM-BIO-75 - 1.5 m2 surface area and Model AM-BIO-100 - 2.0 m2 surface area

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

    Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose 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-BIO-75D - 1.5 m2 surface area and Model AM-BIO-100D - 2.0 m2 surface area

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

    Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures.

    FDA Enforcement
    Class I ·Terminated·Draeger Medical, Inc.·October 16, 2013

    Remel MacConkey Agar w/Sorbitol, growth medium, Catalog R01556, packaged 10/box. The firm name on the label is Remel, Lenexa, KS.

    FDA Recall
    Terminated ·Remel, Inc.·Product code JSI·February 21, 2007

    GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·November 21, 2018

    Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-7409 Explorer - Single End #7 SE. +H65810074090C. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling).

    FDA Recall
    Terminated ·Hu-Friedy Mfg Co, Inc.·Product code EKB·January 7, 2005

    Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma.

    FDA Enforcement
    Class II ·Terminated·Haemonetics Corporation·February 6, 2019

    Clinac (linear accelerator); Model 21EXS Silhouette Machine (slim version of the Clinac); Distributed by and/or Manufactured by: Varian Medical Systems, Palo Alto, CA 94304.

    FDA Recall
    Terminated ·Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304·Product code IYE·March 30, 2005

    BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2) analytes; Epstein-Barr Virus Viral Capsid Antigen (EBV VCA) IgM antibodies and Heterophile antibodies in human serum.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LSE·November 13, 2007

    BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies to three (3) seperate EBV antigens in human serum. They are: 1) Epstein-Barr Virus Nuclear Antigen-1 (EBV-NA-1); 2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D).

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LSE·November 13, 2007

    EBV VCA IgM ELISA 96 Well Kit, Catalog Number: EV012M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.

    FDA Recall
    Terminated ·Calbiotech Inc·Product code LSE·August 27, 2008

    Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.

    FDA Recall
    Terminated ·Diamedix Corporation·Product code LSE·October 20, 2014

    Stryker Trio Mobile Surgery Platform; Model 1033.

    FDA Recall
    Terminated ·Stryker Medical Div. of Stryker Corporation·Product code FSE·May 15, 2006

    BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagent Pack***UNITED STATES, Bio-Rad Laboratories, Inc., Hercules, CA 94547". BioPlex 2200 EBV IgG Calibrator Set is intended for the calibration of the BioPlex 2200 EBV IgG Reagent Pack.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code LSE·March 11, 2011

    DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LSE·November 1, 2004

    Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability

    FDA Recall
    Terminated ·Varian Medical Systems Inc 3100 Hansen Way M/S E-210 Palo Alto CA 94304-1030·Product code IYE·February 4, 2005

    Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument.

    FDA Recall
    Terminated ·Mermaid Medical A/S Frydensbergvej 25 Stenl?se Denmark·Product code DWO·June 15, 2015

    TENET Medical Engineering Wrist Stabilization Kit, Medium; REF (Part) #7692; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.

    FDA Recall
    Terminated ·Tenet Medical Engineering Inc 11979 40th St Se /#203 Ab Calgary Canada·Product code JEB·November 23, 2007

    TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.

    FDA Recall
    Terminated ·Tenet Medical Engineering Inc 11979 40th St Se /#203 Ab Calgary Canada·Product code JEB·November 23, 2007

    TENET Medical Engineering Wrist Stabilization Kit, Large; REF (Part) #7693; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.

    FDA Recall
    Terminated ·Tenet Medical Engineering Inc 11979 40th St Se /#203 Ab Calgary Canada·Product code JEB·November 23, 2007