According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COOPERSURGICAL INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
  • Event Initiated Date
  • Event Country
  • Event Source
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    These products are being recalled due to a labeling error on the secondary package. the current secondary packaging a box incorrectly states that the product is latex free. the product is made with 100% latex. the label on the package that contains the product and the instructions for use (ifu) correctly states that the pessary is manufactured from latex rubber.


  • Model / Serial
    Model Catalog: MXPINFXL (Lot serial: >10 numbers contact mfg); Model Catalog: MXPINFL (Lot serial: >10 numbers contact mfg); Model Catalog: MXPINFM (Lot serial: >10 numbers contact mfg); Model Catalog: MXPINFS (Lot serial: >10 numbers contact mfg)
  • Product Description
    Inflatoball Pessary and Inflatoball Pessary Kit
  • Manufacturer