BEUDAMED
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    Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·May 6, 2026

    9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01

    FDA Recall
    Open, Classified ·ENDO Pharmaceuticals Solutions, Inc.·Product code MDM·November 8, 2022

    ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4

    FDA Recall
    Open, Classified ·Cytrellis Biosystems, Inc.·Product code QAI·June 23, 2023

    Alaris Syringe Module Model 8110 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    AutoMate 1250, Sorter with Aliquot Module - UDI: 15099590364106; Model #ODL25125 Automate 2550, High Speed Sorter with Aliquot Module - UDI: 15099590364083 , Model #ODL25255

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JQP·November 9, 2018

    Alaris PCA Module Model 8120 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only,

    FDA Recall
    Open, Classified ·Allergan Sales, LLC·Product code KDD·March 14, 2024

    Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB

    FDA Recall
    Open, Classified ·AURIS HEALTH INC·Product code FGB·August 2, 2024

    Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code KNS·March 1, 2024

    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L

    FDA Recall
    Open, Classified ·Olympus Corporation of the Americas·Product code KNS·March 1, 2024

    Alaris EtCO2 Module Model 8300 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data.

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·June 30, 2020

    Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.

    FDA Recall
    Open, Classified ·Shimadzu Medical Systems·Product code IZL·November 9, 2020

    Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

    FDA Recall
    Open, Classified ·Datascope Corp.·Product code DSP·February 7, 2023

    Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K05-01018C, K05-01051, K05-01104G, K05-01140D, K05-01194G, K05-01274D, K05-01304A, K05-01756B, K05-01820B, K05-01853A, K05-01855L, K05-01895A, K05-01933A, K05-02161, K05-02431A, K05-02487A, K05-02489C, K05-02495B, K05-02554, K05-02573, K05-02575, K05-02595, K05-02595, K05-02657A, K05-02810, K05-02887, K05-03069A, K05-03095B, K05-03112, K05-03124, K05-03150, K05-50037G

    FDA Recall
    Open, Classified ·Merit Medical Systems, Inc.·Product code OEQ·August 19, 2024

    The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

    FDA Recall
    Open, Classified ·Fresenius Kabi USA, LLC·Product code FRN·February 4, 2026

    Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3

    FDA Recall
    Open, Classified ·Medtronic MiniMed, Inc.·Product code OZP·November 15, 2023

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

    FDA Recall
    Open, Classified ·Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China·Product code KPS·March 1, 2023

    Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps.

    FDA Recall
    Open, Classified ·Quest Medical, Inc.·Product code FPA·July 14, 2023

    Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).

    FDA Recall
    Open, Classified ·Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China·Product code JAK·May 23, 2020