BEUDAMED
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    ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)

    FDA Recall
    Open, Classified ·Sklar Instruments·Product code KCG·December 3, 2024

    Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG (gray, autoclavable) 2087640-001-S FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG, SERVICE (gray, autoclavable) 2096513-001-S FLOW SENSOR ASSEMBLY 5697309 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF BCG 5697310 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code BSZ·August 2, 2021

    V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

    FDA Recall
    Open, Classified ·KCI USA, INC.·Product code OMP·November 5, 2024

    3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US PRE3201 Prevena Plus Peel and Place 35 cm system Kit PRE4000US Prevena Plus 125 Therapy Unit, US PRE4001AU PREVENA PLUS SYSTEM KIT, AU PRE4001CA PREVENA PLUS SYSTEM KIT, CA PRE4001UK PREVENA PLUS SYSTEM KIT, UK PRE4001US PREVENA PLUS SYSTEM KIT, US PRE4001 PREVENA PLUS SYSTEM KIT PRE4001ZA PREVENA PLUS SYSTEM KIT, ZA PRE4010 PREVENA PLUS STANDALONE EXTENDED LIFE SYSTEM KIT PRE5001 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 33X30 CM PRE5101 PREVENA RESTOR ARTHRO-FORM SYSTEM KIT 46X30 CM PRE5221 PREVENA RESTOR BELLA-FORM SYSTEM KIT 21X19 CM PRE5321 PREVENA RESTOR BELLA-FORM SYSTEM KIT 24X22 CM PRE5421 PREVENA RESTOR BELLA-FORM SYSTEM KIT 29X27 CM PRE5501 PREVENA RESTOR AXIO-FORM SYSTEM KIT 29X28 CM

    FDA Recall
    Open, Classified ·KCI USA, INC.·Product code QFC·January 17, 2025

    3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack VIAKIT077D01/GB - V.A.C. VIA 7 Day Kit, Single Shipper

    FDA Recall
    Open, Classified ·KCI USA, INC.·Product code OMP·January 17, 2025

    The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated for each analyte independently of the other analyte. The ALB test is a multilayered, analytical element coated on a polyester support. For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromocresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample. Model/Catalog Number: 6844293

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code CIX·July 10, 2024

    ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FCG·March 31, 2023

    Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.

    FDA Recall
    Open, Classified ·Covidien Llc·Product code FCG·June 26, 2020

    Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guidewire placement to locations of the gastrointestinal tract.

    FDA Recall
    Open, Classified ·Covidien Llc·Product code FCG·June 26, 2020

    BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors.

    FDA Recall
    Open, Classified ·Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438·Product code FCG·August 2, 2024

    To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code FCG·March 31, 2023

    MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14 Gauge 6 cm Length Beveled Sharp Tip Model Number: T146

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code FCG·May 25, 2022

    Medline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B; 2) BREAST BIOPSY TRAY, Pack Number DYNJ32049A ; 3) BREAST BIOPSY PACK, Pack Number DYNJ44987G ; 4) BREAST BIOPSY PACK, Pack Number DYNJ66288

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FCG·April 8, 2024

    EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

    FDA Recall
    Open, Classified ·Cook Medical Incorporated·Product code FCG·April 1, 2024

    Neurotransmitters XL

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code CKG·November 3, 2025

    Neurotransmitters Plus

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code CKG·November 3, 2025

    EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

    FDA Recall
    Open, Classified ·Cook Medical Incorporated·Product code FCG·April 1, 2024

    Neurotransmitters Basic

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code CKG·November 3, 2025