BEUDAMED
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    Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube packaged: 20 tubes/box Product Usage: Brain Heart Infusion Broth with Ciprofloxacin, 1ug is for use as pre-enrichment broth for the cultivation of ciprofloxacin-resistant organisms from clinical samples.

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSO·June 26, 2015

    Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MacConkey Agar with Ciprofloxacin is used as a screening medium for the selective isolation of Ciprofloxacin-resistant E. coli from clinical samples.

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSO·June 26, 2015

    Etest Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

    FDA Recall
    Terminated ·Biomerieux 69280 Marcy Letoile France·Product code JWY·November 19, 2015

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    FDA Recall
    Terminated ·QiG Group LLC·Product code LGW·January 26, 2016

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)

    FDA Recall
    Terminated ·QiG Group LLC·Product code LGW·January 26, 2016

    Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400

    FDA Recall
    Terminated ·QiG Group LLC·Product code LGW·January 26, 2016

    Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube packaged: 20 tubes/box fill: 2ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSO·June 26, 2015

    Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: MDR Acinetobacter is for the primary selective screening for detection and differentiation of multi-drug resistant (MDR) Acinetobacter baumannii.

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSO·June 26, 2015

    Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged: 20 tubes/box fill: 5ml Product Usage: BEA (Bile Esculin Azide) Broth with Vancomycin is for the surveillance of vancomycin resistant enterococci (VRE) not to be used for susceptibility reporting.

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSO·June 26, 2015

    Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate packaged: 10 places/sleeve Product Usage: BEA (Bile Esculin Azide) Agar with Vacomycin, Gentamicin, and Amphotericin B is for the selective isolation of vancomycin resistant enterococci (VRE).

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSO·June 26, 2015

    Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monoplate packaged: 10 plates/sleeve Product Usage: BEA (Bile Esculin Agar) with Azide and Vancomycin for VRE is used as a direct screening medium in the isolation and presumptive identification of vancomycin-resistant enterococci/group D streptococci, such as Enterococcus faecalis and E. faecium, from fecal and rectal cultures.

    FDA Recall
    Terminated ·Hardy Diagnostics·Product code JSO·June 26, 2015

    Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare.

    FDA Recall
    Terminated ·Merge Healthcare, Inc.·Product code OUG·April 4, 2016

    MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System

    FDA Recall
    Terminated ·Product code OUG·September 2, 2021

    AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles.

    FDA Recall
    Terminated ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code OUG·August 8, 2019

    MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code OUG·July 17, 2015

    CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information

    FDA Recall
    Terminated ·Medtronic MiniMed Inc.·Product code OUG·February 19, 2016

    MEDITECH Bi-Directional interactive Communication Analyzer Interface; Integrates with MEDITECH's Laboratory Information System (LIS) with Other Vendor systems to manage the transfer of patient results and demographic information.

    FDA Recall
    Terminated ·Medical Information Technology, Inc. Meditech Circle·Product code OUG·May 7, 2013

    Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management.

    FDA Recall
    Terminated ·Philips Healthcare Informatics, Inc.·Product code OUG·May 5, 2014

    9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),

    FDA Recall
    Terminated ·Pentax of America Inc·Product code OUG·September 22, 2020

    TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as the central operating unit in an operating room. The integration system has two main functions: Recording and distribution of images and videos and interaction with medical and non-medical devices.

    FDA Recall
    Terminated ·Maquet Medical Systems USA·Product code OUG·August 21, 2014