BEUDAMED
    102 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

    FDA Recall
    Open, Classified ·Maquet Cardiopulmonary Gmbh Kehler Str. 31 Rastatt Germany·Product code KRI·June 27, 2025

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·February 20, 2019

    ARIES SARS-CoV-2 Assay

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code QJR·July 14, 2022

    Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZZ·February 20, 2019

    ARIES SARS-CoV-2 Assay, REF: 50-10047

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code QJR·September 14, 2022

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code NJR·February 20, 2019

    ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PGI·February 20, 2019

    ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZN·February 20, 2019

    ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PGX·February 20, 2019

    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZE·February 20, 2019

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    FDA Recall
    Open, Classified ·Remel, Inc·Product code LRG·February 12, 2025

    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

    BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·June 24, 2024

    BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·June 24, 2024

    BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·June 24, 2024

    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·May 2, 2024

    BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·February 14, 2023

    BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·December 3, 2025