BEUDAMED
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    HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code LGZ·October 31, 2016

    Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code LHL·February 15, 2017

    The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert.

    FDA Recall
    Terminated ·Diamedix Corporation·Product code LHL·December 23, 2004

    Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.

    FDA Recall
    Terminated ·Focus Diagnostics Inc·Product code LHL·February 15, 2017

    VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101

    FDA Recall
    Terminated ·bioMerieux·Product code LJC·August 6, 2003

    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.

    FDA Recall
    Terminated ·Northgate Technologies, Inc.·Product code FFK·May 24, 2017

    Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code MID·June 22, 2001

    Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code DHR·November 9, 2001

    Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code LFX·February 24, 2000

    Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code LJB·March 19, 2001

    Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

    Alsius CoolGard Temperature Regulation System

    FDA Recall
    Terminated ·Alsius Corporation·Product code NCX·November 9, 2005

    Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

    Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

    Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

    Alsius Cool Line Catheter, Model CL-2295AE

    FDA Recall
    Terminated ·Alsius Corporation·Product code NCX·January 1, 2007

    Alsius Cool Line Catheter, Model CL-2295A

    FDA Recall
    Terminated ·Alsius Corporation·Product code NCX·January 1, 2007

    Bio-Rad MONOLISA Anti-HBc EIA, Catalog Number 26186. In vitro diagnostic.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·January 7, 2008

    Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display

    FDA Recall
    Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007

    Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam Perfecta w/ gray enclosure and gray colored display

    FDA Recall
    Terminated ·Candela Laser Corporation·Product code GEX·January 15, 2007