Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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The reason for the recall is due to the fact that the identified devices do not meet the requirements of the act or the medical device regulations in that the manufacturer (auradonics inc) does not hold medical device licenses in canada.