BEUDAMED
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    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OJH·January 21, 2020

    TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Recall
    Terminated ·American Optisurgical Inc·Product code LFL·April 30, 2013

    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code LPS·April 1, 2013

    ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code LPS·June 25, 2013

    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code LPS·January 11, 2017

    NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    FDA Recall
    Terminated ·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code HRS·December 19, 2016

    SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    FDA Recall
    Terminated ·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code HRS·December 19, 2016

    Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test Kit, Manufactured at Intersect Systems, Inc., Longview, WA 98632". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1 HCY A (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L (2mL). The second brand name Equal the label reads "EQual DIAGNOSTICS FOR IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog Number E02-058-03, Equal Diagnostic, Exton, PA 19341". The kit is made up of 5 individual portions. These include: Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3, Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All individual kits are packaged into individual boxes and then packaged into 1 box. Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in serum and plasma.

    FDA Recall
    Terminated ·Catch Incorporated·Product code LPS·January 18, 2007

    ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code LPS·November 30, 2018

    Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Caspar Titanium Aneurysm Clip Appliers, Catalog No/Part #: FT420T, Casper Applier F/Mini Ti-Clipsstr 146 mm, Aesculap, Inc., Center Valley, PA. 18034

    FDA Recall
    Terminated ·Aesculap Inc·Product code HCI·November 1, 2007

    Quantam 2000 Electrosurgical Generator, Part number 909075-05.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·October 16, 2019

    Fischer Cone Biopsy Excisor Model: 900-158

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor - Small Model: 900-150

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·October 27, 2014

    Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·March 12, 2018

    Fischer Cone Biopsy Excisor - Medium Model: 900-151

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·June 18, 2019

    Quantam 2000 Electrosurgical Generator, Part number 909075.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·October 16, 2019

    Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006