BEUDAMED
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    Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gravity designed for sterilization of non-porous, heat- and moisture stabile goods, and sterilization of items intended for immediate use. Prevacuum designed for fast, efficient sterilization of porous, heat- and moisture-stabile materials, in addition to the same sterilization capabilities as a Gravity sterilizer.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLE·October 22, 2019

    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. Manufactured by Zeus Scientific, Raritan, NJ 08869-0038. Also manufactured for Wampole Laboratories, Princeton, NJ 08540 Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code LJM·August 19, 2008

    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

    FDA Enforcement
    Class II ·Terminated·Visaris DOO·May 23, 2018

    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

    FDA Enforcement
    Class II ·Terminated·Visaris DOO·May 23, 2018

    Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics

    FDA Enforcement
    Class II ·Terminated·Visaris DOO·May 23, 2018

    Cardiovascular Procedure Kit Part number 70367-07 Mission St. Joe's - Asheville X-Coated Low Prime Pack, Sterile, Terumo Cardiovascular Systems, Ashland, MA. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTQ·May 3, 2011

    Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.

    FDA Enforcement
    Class II ·Terminated·Euro Diagnostica AB·March 14, 2018

    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

    FDA Enforcement
    Class III ·Terminated·Euro Diagnostica AB·July 5, 2017

    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. Product Usage: The DIASTAT anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.

    FDA Recall
    Terminated ·Euro Diagnostica AB·Product code LKJ·October 15, 2015

    DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.

    FDA Recall
    Terminated ·Euro Diagnostica AB·Product code LKJ·May 22, 2017

    Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·September 16, 2005

    BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm x 13 mm); Sterile; REF # 305298 BD, Franklin Lakes, NJ 07417. Made in USA Syringes for use in aspiration and injection of medications.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code MEG·November 24, 2008

    AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017

    AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.

    FDA Recall
    Terminated ·Vyaire Medical·Product code OEV·April 27, 2017