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    EDS Light Suspension, Central Axis, a component of the Stryker Visum LED Surgical Lighting System, with the following catalog numbers: 0682001286, EDS Light Suspension, Central Axis, 5P/FP; 0682001298, EDS Light Suspension, Central Axis, 5P; 0682001299, EDS Light Suspension, Central Axis, 5P/5P; 0682001300, EDS Light Suspension, Central Axis, FP/5P/5P; 0682001432, EDS Light Suspension, Central Axis 9P/FP; 0682001433, EDS Light Suspension, Central Axis, 9P; 0682001434, EDS Light Suspension, Central Axis, 9P/5P; and 0682001435, EDS Light Suspension, Central Axis, FP/9P/5P. Product Usage: The lighting system is intended to illuminate the operative site during surgical procedures with high intensity light.

    FDA Recall
    Open, Classified ·Stryker Communications·Product code FSY·November 13, 2018

    Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code PHX·May 20, 2026

    TECNIS Toric II OptiBlue IOL Models ZCW

    FDA Recall
    Open, Classified ·Johnson & Johnson Surgical Vision, Inc.·Product code MJP·December 12, 2023

    Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

    FDA Recall
    Open, Classified ·Alcon Research LLC Aspex Facility·Product code FWJ·May 23, 2024

    DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).

    FDA Recall
    Open, Classified ·Carestream Health, Inc.·Product code KPR·January 30, 2023

    StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.

    FDA Recall
    Open, Classified ·Medtronic Navigation, Inc.·Product code OLO·August 22, 2024

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

    FDA Recall
    Open, Classified ·Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom·Product code LPS·September 16, 2019

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

    FDA Recall
    Open, Classified ·Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom·Product code LPS·September 16, 2019

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.

    FDA Recall
    Open, Classified ·Axis-Shield Diagnostics, Ltd. 17 Luna Place Dundee United Kingdom·Product code LPS·September 16, 2019

    Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Recall
    Open, Classified ·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024

    Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Recall
    Open, Classified ·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024

    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·February 5, 2025

    Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A

    FDA Recall
    Open, Classified ·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024

    Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·January 24, 2023

    da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·February 10, 2023

    Sedecal NOVA FA DR System. for diagnostic radiography.

    FDA Recall
    Open, Classified ·Sedecal S.A. Pol. Industrial Rio De Janiero Calle Pelaya 9-13 Algete Spain·Product code MQB·July 18, 2018