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Sources: EU EUDAMED, US FDA
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FDA Recall
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Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed,
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code QJZ·December 7, 2021
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code QJZ·April 8, 2024
EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths.
FDA Recall
Open, Classified
·Energetiq Technology Inc·Product code REK·September 27, 2019
Mycoplasma IgM ELISA 96 Well Kit, Catalog Number: MP021M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall
Terminated
·Calbiotech Inc·Product code LJZ·August 27, 2008
EBV VCA IgG ELISA 96 Well Kit, Catalog Number: EV010G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall
Terminated
·Calbiotech Inc·Product code LJZ·August 27, 2008
Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)
FDA Recall
Terminated
·Sakar International, Inc.·Product code DJZ·November 30, 2007
Mycoplasma IgG ELISA 96 Well Kit, Catalog Number: MP020G, The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall
Terminated
·Calbiotech Inc·Product code LJZ·August 27, 2008
0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.
FDA Recall
Terminated
·WNCK, Inc·Product code DJZ·November 30, 2005
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for the semi-quantitative rapid detection of the presence of alcohol in the exhaled breath. The Breath Alcohol Detector indicated relative Blood Alcohol Concentration (BAC) at 0.02%, 0.04%, 0.05%, 0.06%, 0.08%, or 0.10% cut-off levels.
FDA Recall
Terminated
·Acon Laboratories, Inc.·Product code DJZ·June 17, 2015
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
FDA Recall
Terminated
·Meridian Bioscience Inc·Product code LJZ·February 8, 2021