BEUDAMED
    45 results · 37ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Open, Classified × Clear all

    Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·December 22, 2023

    Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·December 22, 2023

    Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·December 22, 2023

    Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·December 22, 2023

    Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·April 24, 2023

    Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·April 24, 2023

    Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·April 24, 2023

    Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port Insertion Pack, and AMS12149 Procedure Pack

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code NGT·August 19, 2021

    Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code LRO·August 16, 2024

    Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code LRO·August 16, 2024

    Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code LRO·August 16, 2024

    Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code LRO·August 16, 2024

    Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code OGR·August 16, 2024

    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·March 11, 2026

    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·March 11, 2026

    Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994

    FDA Recall
    Open, Classified ·Windstone Medical Packaging, Inc.·Product code KDD·March 11, 2026

    Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x and 5.0.0

    FDA Recall
    Open, Classified ·Hermes Medical Solutions AB Strandbergsgatan 16 Stockholm Sweden·Product code KPS·October 31, 2024

    PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050

    FDA Recall
    Open, Classified ·Oculus Technologies of Mexico, S.A. de C.V. Calle Industria Vidriera 81 Industrial Zapopan Norte Zapopan Mexico·Product code FRO·April 27, 2026

    Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPR·March 10, 2025

    Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code KPR·March 10, 2025