Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.
Unlicensed medical devices "Cryosaunas" illegally imported to Canada and possibly linked to a death in the U.S.
- Starting date:
- December 18, 2015
- Posting date:
- December 18, 2015
- Type of communication:
- Medical Device
- Source of recall:
- Health Canada
- Important Safety Information, Unauthorized products
- General Public
- Identification number:
- What you should do
- Who is affected
- Media enquiries
- Public enquiries
- What Health Canada is doing
Health Canada is advising Canadians that several clinics in Ontario and at least one in Québec are currently using illegally imported medical devices, Cryosaunas, which are potentially linked to a death in the US. Cryosaunas use liquid nitrogen to expose users to cold air (at or below -200-300°F) for several minutes for the purpose of "whole body therapy".
What you should do
- Consult your health care provider if you have used this device.
- Report any adverse events to Health Canada.
- Report complaints about health products to Health Canada by calling toll-free to 1-800-267-9675, or complete an online complaint form.
Who is affected
Any Canadian who uses Cryosaunas.
What Health Canada is doing
Health Canada has requested that the manufacturer stop the sale and immediately recall the unlicensed Class III devices. Health Canada has informed clinics who are currently using this device to advise them of the serious potential health risk.
Health Canada is also working with the Canadian Border Services Agency to help prevent further illegal importation of Cryosaunas.
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
- Date modified: