BEUDAMED
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    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·March 9, 2011

    HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips

    FDA Recall
    Open, Classified ·Universal Meditech Inc.·Product code JIN·May 22, 2023

    VICRYL* UND 3-0 70CM (1)SC-20

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·September 22, 2020

    HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. 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

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·July 9, 2025

    Dental Explorer #2 D/E, Mfr. Part Code/Product Code 101-0913, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. Product is labeled in part, HENRY SCHEIN 101-0913 Explorer #2 D/E. +H658101091306. 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

    ACCESS® TOTAL BETA-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JHI·February 16, 2012

    Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, 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 100-8008 Explorer-Double End #5. +H658100800808. 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

    B-K Medical Intraoperative Transducer Type 8814, diagnostic ultrasound transducer, B-K Medical Systems, Inc., Wilmington, MA 01887

    FDA Recall
    Terminated ·B & K Medical Systems, Inc.·Product code IYN·January 24, 2008

    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

    Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C

    FDA Recall
    Terminated ·Orthofix, Inc·Product code HRS·April 6, 2018

    Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C

    FDA Recall
    Terminated ·Orthofix, Inc·Product code HRS·April 6, 2018

    Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C

    FDA Recall
    Terminated ·Orthofix, Inc·Product code HRS·April 6, 2018

    RLSense, Restless Legs Sensor, Proto6, Rev-J Firmware RLSense is a pair of disposable adhesive patches applied to the dorsum of the feet. Each patch contains a microprocessor, memory, movement sensor, and a small coin-type battery. The devices record periodic movements of the feet and legs during the night.

    FDA Recall
    Terminated ·Sleep Modus·September 15, 2010

    Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 Performing ultrasound guided biopsies of the prostate.

    FDA Recall
    Terminated ·Bk Medical Mileparken 34 Iierlev Denmark·September 8, 2008

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    VITEK 2 Gram Negative Susceptibility Card, AST-N172, REF 410 298, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-N090, REF 22 240, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-GN35, REF 22 286, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010

    VITEK 2 Gram Negative Susceptibility Card, AST-GN43, REF 410 759, For In Vitro Diagnostic Use, 20 cards/box. The firm names on the label are bioMerieux, Inc., Durham, NC, and bioMerieux sa, 69280 Marcy-l'Etoile France.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LON·September 16, 2010