Fraudulent and unauthorized N95 respirators may not protect consumers against COVID-19

Starting date:
April 14, 2020
Type of communication:
Advisory
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-72707

Last updated:

Summary

  • Product: Fraudulent N95 respirators
  • Issue: Health Canada is warning Canadians about the risks of using fraudulent and unauthorized N95 respirators, as they may not protect consumers against COVID-19.
  • What to do: Check whether your N95 respirator has been certified by the U.S. National Institute for Occupational Safety and Health (NIOSH). If your mask is fraudulent or unauthorized, stop using it as it may not protect you against COVID-19.

OTTAWA - Health Canada has received reports that fraudulent and uncertified N95 respirators that falsely claim to protect consumers against COVID-19 are being illegally sold to consumers online and in some stores.

In Canada, N95 respirators are regulated by Health Canada as Class I medical devices and are manufactured or imported by companies that hold a Medical Device Establishment Licence. They are also certified by the U.S. National Institute for Occupational Safety and Health (NIOSH).

Fraudulent or unauthorized N95 masks may not meet the same performance measures required by the NIOSH N95 standard and, as a result, may not properly protect consumers from COVID-19.

When worn properly, NIOSH-certified N95 respirators are designed to secure a close facial fit and reduce the risk of inhaling hazardous airborne particles and aerosols. The "N95" designation means that when subjected to careful testing, the respirator blocks at least 95% of very small test particles, such as pathogens.

For a depiction of the NIOSH symbol, refer to the NIOSH website.

It is illegal to sell or advertise health products that make false or misleading claims. The Department takes this issue seriously and will use all available tools to stop these activities.

Health Canada monitors websites and takes action when false claims and/or unauthorized products are identified, and is working with online retailers to ensure that these products are removed from their websites.

Health Canada is also working with other government departments and agencies―such as the Competition Bureau, the Public Health Agency of Canada, and the Canada Border Services Agency―to address the issue of false and misleading claims related to COVID-19 and will continue to take compliance and enforcement actions to protect the health and safety of Canadians.

What you should do

  • Learn about the proper use of face masks.
  • Confirm that your product has been certified by NIOSH by entering the approval number, which can be found on the respirator, in the NIOSH database.
  • Review the product package and respirator to ensure it has the appropriate markings and details, as required by NIOSH. This includes the TC (Testing and Certification) approval number (a number set by NIOSH), the name of the manufacturer, the NIOSH name or logo, the model number, and filter efficiency (N95).
  • Look at product markings, such as the name of the manufacturer, to determine whether there are any obvious signs that the product is counterfeit (e.g., incorrect spelling).
  • If your mask is fraudulent or uncertified, stop using it.
  • Report information on the potential false or misleading advertising or sale of unauthorized products to Health Canada.

More information about buying health products safely is available on Health Canada's website.

For the latest and most up-to-date information on COVID-19 visit Canada.ca/coronavirus.

Media enquiries

Media Inquiries:
Health Canada
613-957-2983
hc.media.sc@canada.ca

Public enquiries

Public Inquiries:
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1-833-784-4397