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    BD Synapsys Informatics Solution, Catalog Number 444150

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·June 8, 2023

    BD Synapsys Informatics Solution (Laboratory Solution) Version or Model: 444150 Catalog Number: 444150

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·October 31, 2024

    BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution; Catalog (Ref): 444900;

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code KZB·July 9, 2024

    Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001

    FDA Recall
    Open, Classified ·Roche Diabetes Care, Inc.·Product code NBW·July 28, 2021

    BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code JQP·September 12, 2024

    HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (EMR) and Clinical Information System (CIS).

    FDA Recall
    Open, Classified ·Covidien LLC·Product code MWI·January 30, 2026

    Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VIPER integrates multiple information feeds that supports the real-time distribution of critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, complication, and sophisticated alerting systems, VIPER offers improved support for the avoidance of adverse events.

    FDA Recall
    Open, Classified ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code MWI·March 19, 2025

    The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code GFO·December 11, 2025

    PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code CAH·July 18, 2023

    APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.

    FDA Recall
    Open, Classified ·Medartis Inc.·Product code HWC·April 12, 2024

    EasyPoint Needle, 25G x 5/8", REF: 82091

    FDA Recall
    Open, Classified ·Retractable Technologies, Inc.·Product code FMI·February 5, 2024

    TMJ Bilateral Implants, REF: CHG020

    FDA Recall
    Open, Classified ·TMJ Solutions Inc·Product code LZD·February 11, 2026

    Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310

    FDA Recall
    Open, Classified ·PFM MEDICAL INC.·Product code DXE·April 21, 2026

    LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400

    FDA Recall
    Open, Classified ·MICROVENTION INC.·Product code KRD·May 29, 2025

    Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.

    FDA Recall
    Open, Classified ·Mobius Imaging, LLC·Product code JAK·December 4, 2025

    KliniTray Platte Faxitron ,groB "R" sterile. Tissue resection margin examination board/large Model Number: 2001155-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.

    FDA Recall
    Open, Classified ·Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany·Product code FMH·April 4, 2025

    KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.

    FDA Recall
    Open, Classified ·Klinika Mdical Gmb Achtzehnmorgenweg 6 Usingen Germany·Product code FMH·April 4, 2025

    Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.

    FDA Recall
    Open, Classified ·Mobius Imaging, LLC·Product code JAK·December 4, 2025

    Brand Name: Quantum Informatics - VISION / LIVE VUE Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VISION / LIVE VUE is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice solutions for the high-risk patient population in the operating room (OR). VISION / LIVE VUE integrates multiple information feeds that supports remote monitoring of near real-time critical patient information and the deployment of advanced active Patient Safety Systems and clinical Best Practice. By integrating compliance, critical care scoring systems, and sophisticated alerting systems, VISION / LIVE VUE offers improved support for ensuring compliance to hospital-specific protocols. The software solution also allows for big data queries, routine reporting, and review of quality performance metrics.

    FDA Recall
    Open, Classified ·Spectrum Medical Ltd. Harrier 4, Meteor Business Park Cheltenham Road East Gloucester United Kingdom·Product code MWI·March 19, 2025

    Bodor P and C series laser cutting machines

    FDA Recall
    Open, Classified ·Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China·Product code RFE·December 19, 2024