BEUDAMED
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    SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    FDA Recall
    Open, Classified ·Glycar SA Pty., Ltd.·Product code DXZ·October 9, 2025

    Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

    FDA Recall
    Open, Classified ·Ellex Medical Pty Ltd.·Product code HQF·March 16, 2023

    Clarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a) Clarity Strep A Rapid Test, Part Number CD-STP25, b) Clarity Diagnostics LLC, Clarity Strep A Rapid Test, Part Number CD-STP25V

    FDA Recall
    Open, Classified ·Wondfo USA Co Ltd·Product code GTY·April 22, 2024

    Independent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep A Rapid Test Strip and IMCO Strep A Rapid Test, Part Number STP25-IMC

    FDA Recall
    Open, Classified ·Wondfo USA Co Ltd·Product code GTY·April 22, 2024

    Preview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b) PRE-STA-A-10

    FDA Recall
    Open, Classified ·Wondfo USA Co Ltd·Product code GTY·April 22, 2024

    Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250

    FDA Recall
    Open, Classified ·Bridge to Life Ltd·Product code KDN·June 12, 2025

    SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    FDA Recall
    Open, Classified ·Glycar SA Pty., Ltd.·Product code DXZ·October 9, 2025

    Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

    FDA Recall
    Open, Classified ·Acon Biotech (Hangzhou) Co., Ltd.·Product code QKP·January 9, 2022

    McKesson Cardiology Hemo software

    FDA Recall
    Open, Classified ·A L I Technologies Ltd·Product code MWI·December 2, 2024

    Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays.

    FDA Recall
    Open, Classified ·The Binding Site Group, Ltd.·Product code OTA·April 16, 2026

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Recall
    Open, Classified ·Guangzhou Wondfo Biotech Co., Ltd.·Product code DIS·May 18, 2018

    Change Healthcare Cardiology Hemodynamics software

    FDA Recall
    Open, Classified ·A L I Technologies Ltd·Product code MWI·December 2, 2024

    HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.

    FDA Recall
    Open, Classified ·Leica Biosystems Melbourne Pty Ltd·Product code IEO·April 2, 2025

    Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No

    FDA Recall
    Open, Classified ·Guangzhou Pluslife Biotech Co., Ltd.·Product code QKP·January 24, 2025

    RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and infectious materials.

    FDA Recall
    Open, Classified ·Smith & Nephew Medical, Ltd.·Product code OMP·October 2, 2024

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Recall
    Open, Classified ·Guangzhou Wondfo Biotech Co., Ltd.·Product code DIS·May 18, 2018

    Change Healthcare Cardiology Hemo software

    FDA Recall
    Open, Classified ·A L I Technologies Ltd·Product code MWI·December 2, 2024

    RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139

    FDA Recall
    Open, Classified ·Smith & Nephew Medical, Ltd.·Product code OMP·March 11, 2024

    TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S) Product Usage: T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive.

    FDA Recall
    Open, Classified ·Guangzhou Wondfo Biotech Co., Ltd.·Product code DIS·May 18, 2018

    RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140

    FDA Recall
    Open, Classified ·Smith & Nephew Medical, Ltd.·Product code OMP·March 11, 2024