Unauthorized soft-shelled hyperbaric chambers may pose serious health risks 2026-06-16

Issue

Health Canada has received several complaints related to the use of unauthorized soft-shelled hyperbaric chambers and they are increasingly found in wellness centres in Canada. Soft-shelled hyperbaric chambers are regulated as medical devices under the Food and Drugs Act and Medical Devices Regulations. These devices are unlicensed, may be ineffective for the purposes for which they are advertised and may pose serious health risks for users and those in close proximity, including death.Soft-shelled hyperbaric chambers may catch fire, especially when used in combination with an oxygen concentration device. They can suffocate users, spread infectious diseases between users, cause damage to ears, eyes, sinuses, lungs and teeth, and change blood sugar levels.To date, Health Canada has not authorized any soft-shelled hyperbaric chamber for sale in Canada, as it has not received the evidence needed to confirm that these devices meet Health Canada's safety, effectiveness or quality requirements. As a result, it is illegal to import, sell and advertise soft-shelled hyperbaric chambers in Canada.Do not confuse soft-shell hyperbaric chambers with hard-shell hyperbaric chambers. Hard-shell devices are proven to treat 14 specific conditions. You can learn more about hard-shell hyperbaric chambers on Health Canada's website.The Department is following up on complaints and will take compliance and enforcement actions, as needed, to mitigate the risk to Canadians using the most appropriate level of intervention, in accordance with its Compliance and enforcement policy for health products.

What you should do

• Do not use soft-shelled hyperbaric chambers.
• Consult a healthcare practitioner if you have used a soft-shelled hyperbaric chamber and you have concerns about your health.
• Only use licensed medical devices. Check whether medical devices have been authorized for sale in Canada by searching Health Canada's Medical Devices Active Licence Listing.
• Report complaints involving medical devices, including health complications or the sale of unlicensed devices, to Health Canada.