BEUDAMED
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    Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT

    FDA Recall
    Open, Classified ·Penner Patient Care, Inc.·Product code ILJ·August 13, 2025

    NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250

    FDA Recall
    Open, Classified ·Ace Surgical Supply Co., Inc.·Product code NPM·February 2, 2022

    FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·January 26, 2024

    xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.

    FDA Recall
    Open, Classified ·Luminex Molecular Diagnostics·Product code PCH·February 22, 2019

    Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift

    FDA Recall
    Open, Classified ·Acorn Stairlifts, Inc·Product code PCD·April 20, 2016

    Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PCH·June 5, 2023

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·April 25, 2023

    Intestinal Worms Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code PCH·November 3, 2025

    GI Microbiome Profile Small

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code PCH·November 3, 2025

    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    GI Microbiome Profile XL

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code PCH·November 3, 2025

    Parasite Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code PCH·November 3, 2025

    VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PCH·March 18, 2021

    VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PCH·June 17, 2022

    In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·February 1, 2023

    FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·March 8, 2023

    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code PCH·November 27, 2023

    Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    FDA Recall
    Open, Classified ·Medtronic Neurosurgery·Product code PCB·January 22, 2024