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
    Coopersurgical is advising all frigitronics cryo-plus cryosugery system users that there are questions regarding the validity of the current high level disinfection procedure for the shaft of the system's hand piece. this notification does not include any cryosurgical tips which currently have a validated high level disinfection procedure. therefore coopersurgical is advising all customers of record to practice all necessary diligence when using the device.


  • Model / Serial
    Model Catalog: 2400 (Lot serial: All lots); Model Catalog: 2401 (Lot serial: All lots); Model Catalog: 2402 (Lot serial: All lots); Model Catalog: 50502 (Lot serial: All lots); Model Catalog: 50501 (Lot serial: All lots)
  • Product Description
    Frigitronics Cryo-Plus Cryosurgery System
  • Manufacturer