BEUDAMED
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    Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision Laser System No Bed, Models: 0160-6020 (United States), 0160-6010 (International)

    FDA Recall
    Open, Classified ·AMO Manufacturing USA, LLC·Product code OOE·October 21, 2021

    Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330

    FDA Recall
    Open, Classified ·Zoe Medical Incorporated·Product code DQA·August 13, 2024

    Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

    FDA Recall
    Open, Classified ·Zoe Medical Incorporated·Product code DQA·August 13, 2024

    VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged

    FDA Recall
    Open, Classified ·Greiner Bio-One North America, Inc.·Product code JKA·May 14, 2024

    Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)

    FDA Recall
    Open, Classified ·Greiner Bio-One North America, Inc.·Product code JKA·August 19, 2025

    Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322

    FDA Recall
    Open, Classified ·Greiner Bio-One North America, Inc.·Product code GIM·August 8, 2025

    VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.

    FDA Recall
    Open, Classified ·Greiner Bio-One North America, Inc.·Product code JKA·December 12, 2023

    VACUETTE SAFELINK, REF: 450210

    FDA Recall
    Open, Classified ·Greiner Bio-One GmbH Bad Haller Strase·Product code FMI·November 19, 2024

    The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses.

    FDA Recall
    Open, Classified ·Quidel Corporation·Product code QMN·January 3, 2024

    IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code DSI·March 28, 2019

    IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code DSI·March 28, 2019

    IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 453564615331, 453564615351, and 453564615371 Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code DSI·March 28, 2019

    Lazervida 10W diode laser cutter and engraver with Lazervida shield.

    FDA Recall
    Open, Classified ·Flux Technology Inc.·Product code RHK·February 19, 2025

    NOxBOXi Nitric Oxide Delivery System

    FDA Recall
    Open, Classified ·NOXBOX LTD·Product code MRN·July 19, 2023

    IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811, 453564467721, 453564467741, 453564467761, 453564467781, 453564467801, 453564467821, 453564467841, 453564467861, 453564262531, and 453564262551 - Product Usage: Used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network. When the MX40 is connected to the IntelliVue Information Center the IntelliVue Information Center provides the primary patient monitoring and alarming function. The MX40 does not automatically provide local monitoring or alarming when connected to the Information Center.

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code DSI·March 28, 2019

    MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MWI·September 6, 2022

    The Non-Sterile Flyte hood covers the user s head and neck region and is intended to be worn with commercially available gowns. The hood is donned after the Flyte helmet and before the gown, such that the hood is securely tucked inside the gown. The hood attaches to and covers the helmet and air is drawn into the helmet through a filter located on the top-backside of the hood. The filtered air is delivered into the helmet and the disposable does not inhibit adjustment of helmet settings/functions. Catalog Number: 0408-800-000NS

    FDA Recall
    Open, Classified ·Stryker Corporation·Product code OEA·June 3, 2024

    Smaxel Fractional CO2 Laser, a Class IV medical laser system.

    FDA Recall
    Open, Classified ·IDS LTD 194 Simgung-Ro Gwangtan-Myeon Paju Korea (the Republic of)·Product code ONG·October 16, 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

    UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach Material No.M0068318220 Individually packaged Upsylon Y Mesh (UPN M0068318200) is not impacted by this removal. Note: The UpsylonTM Y Mesh Kit consists of UpsylonTM Y Mesh and ColpassistTM Vaginal Positioning Device packaged and sterilized separately and then combined into a kit carton. This removal does not affect the UpsylonTM Y Mesh component of the kit, however, since the Colpassist device component is impacted, the entire UpsylonTM Y Mesh kit is being removed.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code OHD·April 15, 2021