BEUDAMED
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    CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

    FDA Recall
    Terminated ·Centers For Disease Control and Prevention·Product code OZE·April 26, 2024

    CDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11

    FDA Enforcement
    Class II ·Terminated·Centers For Disease Control and Prevention·July 3, 2024

    HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.

    FDA Enforcement
    Class II ·Terminated·ASO, LLC·August 14, 2013

    Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical KIT

    FDA Enforcement
    Class II ·Terminated·Covidien LLC·July 29, 2015

    Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical KIT

    FDA Recall
    Terminated ·Covidien LLC·Product code FSY·April 16, 2015

    HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds.

    FDA Recall
    Terminated ·ASO, LLC·Product code MGO·July 26, 2013

    ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH·July 2, 2014

    Newport HT50 Ventilator. Model #HT50 H1-B The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support.

    FDA Recall
    Terminated ·Newport Medical Instruments Inc·Product code CBK·January 13, 2009

    Newport HT50 Ventilator. Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs)

    FDA Recall
    Terminated ·Newport Medical Instruments Inc·Product code CBK·May 14, 2010

    Sterile Multi-Purpose Solution, NO RUB, for soft hydrophylic contact lenses. 12 fl oz. bottles. Sold under the following brand names: Family Dollar HomeBest HEB Meijer Food Lion health PRIDE Stop and Shop Super G sunmark Brite-Life Wegmans Our Family Healthy Generations GoodSense Winn Dixie Finast Western Family K C Pharmaceuticals

    FDA Recall
    Terminated ·K C Pharmaceuticals Inc·Product code LPN·October 4, 2004

    Newport HT50 Ventilator, Model # HT-50-H, HT50-HB, HT50-H1, and HT50-H1B Product Code: NOU The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22Ibs), who require the following general types of ventilatory support: positive pressure ventilation with Assist/Control, SIMV and SPONT/CPAP modes of ventilation. The NEWPORT HT50 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

    FDA Recall
    Terminated ·Newport Medical Instruments Inc·Product code CBK·July 22, 2009

    Gold Hub Finesse Cannula, Catalog Nos. HK10F23; HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23; HK16F5; HK16F8

    FDA Recall
    Terminated ·HK Surgical Inc·Product code FIE·December 3, 2004

    Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.

    FDA Recall
    Terminated ·HK Surgical Inc·Product code FIE·December 3, 2004

    Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6

    FDA Recall
    Terminated ·HK Surgical Inc·Product code FIE·December 3, 2004

    Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 190. Calibrator designed for the calibration of Roche assays for the quantitative determination of certain drugs concentrations in human serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code DKB·April 22, 2009

    HENRY SCHEIN(R) 100-3620 Explorer-Single End #23 SE. Barcode *+H658100362003*. 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). 510 (k) exempt, Class I device, Device Listing # B057701.

    FDA Recall
    Terminated ·Hu-Friedy Mfg Co, Inc.·Product code EKB·March 29, 2004

    Dental Explorer #23 S/E, Mfr. Part Code/Product Code 100-3620, 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 100-3620 Explorer-Single End #23 SE. +H658100362003. 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

    Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards, packaged in boxes containing Levels 1-6, 1 x 4 mL each, REF 2450-604, Medline catalog number S-O2450604, IVD.

    FDA Recall
    Terminated ·MEDLINE INDUSTRIES, LP Northfield·Product code DKB·March 8, 2022

    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

    Multi-Analyte Urine DAU Calibrator (15 mL HDPE bottle inside a cardboard box) For in vitro diagnostic use only. Lin-Zhi International, Inc.. 670 Almanor Ave. Sunnyvale, CA 94085 intended use: Drug abuse detection.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DKB·August 23, 2011