BEUDAMED
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    Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01

    FDA Recall
    Open, Classified ·Mindray DS USA, Inc. dba Mindray North America·Product code MSX·February 22, 2021

    Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1)

    FDA Recall
    Open, Classified ·Mindray DS USA, Inc. dba Mindray North America·Product code MSX·November 18, 2025

    CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

    FDA Recall
    Open, Classified ·Philips North America·Product code MSX·February 28, 2024

    SMV DSX New Line, System, Tomography, Computed, Emission

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code IYX·December 10, 2025

    Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code JAK·March 26, 2026

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·December 20, 2024

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·December 20, 2024

    Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.

    FDA Recall
    Open, Classified ·Max Mobility LLC·Product code ITI·August 12, 2025

    Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)

    FDA Recall
    Open, Classified ·MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany·Product code NFJ·September 9, 2025

    ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35

    FDA Recall
    Open, Classified ·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024

    Alinity i Anti-HCV Reagent Kit, List Number 08P0521

    FDA Recall
    Open, Classified ·Abbott GmbH Max-Planck-Ring 2 Wiesbaden Germany·Product code MZO·March 4, 2024

    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code HSX·March 21, 2023

    Gonorrhea test

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

    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code HSX·March 21, 2023

    LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code HSX·March 21, 2023

    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code HSX·March 21, 2023

    LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code HSX·March 21, 2023

    Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300, SIZE 3-LEFT MEDIAL; f) REF 1-10012-350, SIZE 3-RIGHT MEDIAL; g) REF 1-10012-400, SIZE 4-LEFT MEDIAL; h) REF 1-10012-450, SIZE 4-RIGHT MEDIAL; i) REF 1-10012-500, SIZE 5-LEFT MEDIAL; j) REF 1-10012-550, SIZE 5-RIGHT MEDIAL; k) REF 1-10012-600, SIZE 6-LEFT MEDIAL; l) REF 1-10012-650, SIZE 6-RIGHT MEDIAL; Unicondylar knee prothesis

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code HSX·May 2, 2023