BEUDAMED
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    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories·Product code OYX·February 15, 2024

    Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

    FDA Recall
    Open, Classified ·Cepheid·Product code OYX·October 30, 2025

    Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10

    FDA Recall
    Open, Classified ·Cepheid·Product code OYX·October 30, 2025

    GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ONE-A1-1B, ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, 20/BOX; 2. ONE-A1-2A, ONE-CUF, SMALL ADULT, DINACLICK 80369-5, 17 - 25 CM, 20/BOX; 3. ONE-A2-1B, ONE-CUF, ADULT, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 4. ONE-A1-1B-L, ONE-CUF, ADULT LONG, 1 TB BAYONET, 23 - 33 CM, 20/BOX; 5. ONEA2-2A, ONE-CUF, ADULT, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 6. ONE-A2-2A-L, ONE-CUF, ADULT LONG, DINACLICK 80369-5, 23 - 33 CM, 20/BOX; 7. ONE-A3-1B, ONE-CUF, LARGE ADULT, 1 TB BAYONET, 31 - 40 CM, 20/BOX; 8. ONE-A3-2A, ONE-CUF, LARGE ADULT, DINACLICK 80369-5, 31 - 40 CM, 20/BOX; 9. ONE-P1-1B, ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM, 20/BOX; 10. ONE-P1-2A, ONE-CUF, INFANT, DINACLICK 80369-5, 08 - 13 CM, , 20/BOX; 11. ONE-P2-1B, ONE-CUF, CHILD, 1 TB BAYONET, 12 - 19 CM, 20/BOX; and 12. ONE-P2-2A, ONE-CUF, CHILD, DINACLICK 80369-5, 12 - 19 CM, 20/BOX.

    FDA Recall
    Open, Classified ·GE Medical Systems Information Technologies Inc·Product code DXQ·April 9, 2024

    Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. Model number/Catalog number: L741

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EBL·March 18, 2021

    Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

    FDA Recall
    Open, Classified ·Conavi Medical Inc.·Product code OBJ·March 12, 2025

    1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting LVAD patients. Along with being able to program and monitor the LVAS, the HeartMate Touch Application introduces features that enables users to setup pairing and connection with the existing HeartMate 3 Left Ventricular Assist System (LVAS) via the HeartMate Touch Wireless Adapter and generate reports from the log files that are downloaded from the HM3 System Controller.

    FDA Recall
    Open, Classified ·Thoratec Corp.·Product code DSQ·January 3, 2024

    AlternatiV+ Screw-In Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Fixone Hybrid Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Genesis Screw-In Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Genesis Dual Thread Screw-In Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    AlternatiV+ Max Knotless Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Fixone Biocomposite Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Genesis Push-In Suture Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025

    Genesis Knotless Anchor

    FDA Recall
    Open, Classified ·Aju Pharm Co., Ltd. Room 201, Room 207, Bl A Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025