BEUDAMED
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    Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·August 20, 2007

    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

    FDA Recall
    Terminated ·Biomet Spine, LLC·Product code KWQ·August 5, 2015

    Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·August 11, 2005

    Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JWH·August 11, 2005

    i-STAT PT/INR Cartridge Abbott Point of Care, Princeton, NJ

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code GJS·May 5, 2010

    BD Vacutainer Urine Complete Kit with UA Preservative Tube and C&S Preservative Tube for Midstream Specimens PLUS Plastic, Sterile Cup and Tube Interiors. Store at 4-25 degrees C. For In Vitro Diagnostic Use. Becton Dickinson and Company, Franklin Lakes, NJ.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JSM·October 12, 2009

    BD Vacutainer Urine Complete Kit with UA Tube and S&C Preservative Tube for Midstream specimens; Plus Plastic - Sterile Cup and Tube interiors. Store at 4-25 degrees C. Kit contains Sterile Screw CAP Collection Cup with integrated Transfer Device and 8.0 mL, 16/x100 mm PLUS Plastic Conical Tube for Urinalysis and 4.0 mL 13x75mm Plus Plastic C&C Preservative tube and Castile Soap Towelettes; Becton Dickinson and Company, Franklin Lakes, NJ

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code JSM·October 12, 2009

    MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.

    FDA Recall
    Terminated ·Southern Implants, Inc·Product code DZE·January 23, 2015

    Mycoplasma IgM ELISA 96 Well Kit, Catalog Number: MP021M 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 LJZ·August 27, 2008

    EBV VCA IgG ELISA 96 Well Kit, Catalog Number: EV010G 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 LJZ·August 27, 2008

    Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

    FDA Recall
    Terminated ·Gen Probe Inc·Product code NDZ·June 11, 2004

    Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)

    FDA Recall
    Terminated ·Sakar International, Inc.·Product code DJZ·November 30, 2007

    Mycoplasma IgG ELISA 96 Well Kit, Catalog Number: MP020G, 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 LJZ·August 27, 2008

    0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.

    FDA Recall
    Terminated ·WNCK, Inc·Product code DJZ·November 30, 2005

    Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.

    FDA Recall
    Terminated ·Acon Laboratories, Inc.·Product code DJZ·June 17, 2015

    The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code LJZ·February 8, 2021

    CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order of the treating doctor.

    FDA Recall
    Terminated ·TERRIFIC CARE LLC 61 Willet St Bldg A-1, Fl 2 Passaic NJ 07055-1971·Product code GJS·December 20, 2018

    MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

    FDA Recall
    Terminated ·Linde Gas North America Llc 575 Mountain Ave Attn Import Compliance Manager New Providence NJ 07974·Product code CAN·March 8, 2013