BEUDAMED
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    Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

    FDA Enforcement
    Class II ·Completed·Beckman Coulter, Inc.·July 23, 2025

    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

    FDA Enforcement
    Class II ·Completed·Beckman Coulter Mishima K.K.·June 11, 2025

    Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

    FDA Enforcement
    Class II ·Completed·Beckman Coulter Mishima K.K.·June 11, 2025

    Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

    FDA Recall
    Completed ·Beckman Coulter, Inc.·Product code CDD·February 27, 2025

    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    FDA Enforcement
    Class II ·Completed·Bio-Rad Labs·May 6, 2020

    Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

    FDA Recall
    Completed ·Bio-Rad Labs·Product code MVM·April 3, 2019

    PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

    FDA Recall
    Completed ·Cardinal Health 200, LLC·Product code KGO·July 29, 2020

    PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

    FDA Recall
    Completed ·Cardinal Health 200, LLC·Product code KGO·July 29, 2020

    PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

    FDA Recall
    Completed ·Cardinal Health 200, LLC·Product code KGO·July 29, 2020

    PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

    FDA Recall
    Completed ·Cardinal Health 200, LLC·Product code KGO·July 29, 2020

    PROTEXIS Latex Micro Surgical Gloves Size 8.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

    FDA Recall
    Completed ·Cardinal Health 200, LLC·Product code KGO·July 29, 2020

    PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

    FDA Recall
    Completed ·Cardinal Health 200, LLC·Product code KGO·July 29, 2020

    PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

    FDA Recall
    Completed ·Cardinal Health 200, LLC·Product code KGO·July 29, 2020

    PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

    FDA Recall
    Completed ·Cardinal Health 200, LLC·Product code KGO·July 29, 2020

    VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test

    FDA Recall
    Completed ·Luminex Corporation·Product code PEN·April 16, 2025

    Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

    FDA Recall
    Completed ·Cardinal Health 200, LLC·Product code KGO·March 15, 2022

    POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·June 25, 2018

    MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    FDA Recall
    Completed ·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·October 29, 2020

    MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.

    FDA Recall
    Completed ·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·October 29, 2020

    LYFO Disk

    FDA Recall
    Completed ·Microbiologics Inc·Product code JTR·July 17, 2015