Counterfeit respirators

Starting date:
July 6, 2020
Type of communication:
Advisory
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-73493

Last updated:

Summary

  • Product: Counterfeit respirators
  • Issue: Health Canada is warning Canadians about the risks of using counterfeit respirators as they may not protect Canadians against the virus that causes COVID-19.
  • What to do: If your mask is counterfeit, stop using it. Report any health product adverse events or complaints to Health Canada.

Issue

Health Canada has identified counterfeit respirators in Canada and is advising consumers to stop using them as they may not protect Canadians against the virus that causes COVID-19. Counterfeit respirators are imitations of legitimate products. There are no assurances that they provide protection or prevent harm.

Health Canada is taking action to stop the import and sale of counterfeit respirators in Canada. The Department directs companies that may be importing or distributing these respirators to remove them from the market since they are not permitted to be sold in Canada. Health Canada will also cancel authorizations when there are reasonable grounds to believe that a product is counterfeit.

Health Canada will continue to take action and update the list of counterfeit respirators below as needed.

Affected products

Health Canada has identified the following respirators as being counterfeit.

The table below will be updated on a regular basis as Health Canada obtains new information. Consumers are encouraged to check back often.

Please note that the devices in the table are listed alphabetically, rather than by the date they were added.

Distributor, Importer or Manufacturer Device Additional Information Action Taken

Shanghai Lansheng Light Industrial Products

(Manufacturer)

Counterfeit
N95 particulate respirator

Shanghai Lansheng Light Industrial Products was found to be selling counterfeit N95 respirators under another company's name (Shanghai Dasheng Health Products Manufacture Co. Ltd) and using its device number (DTC3X N95).

The counterfeit respirators were falsely labeled, marketed and sold as NIOSH-approved, and may not provide the stated protection.

Interim Order Authorization #314322 was cancelled on June 17, 2020.

Shanghai Lansheng was directed to stop sale and recall the product.

Health Canada is working with the Canada Border Services Agency to prevent the importation of this product.

 

What you should do

  • Check whether your N95 respirator has been tested and certified by the U.S. National Institute for Occupational Safety and Health (NIOSH), which provides tips on how to identify legitimate and counterfeit products on its website, or whether it is on the list of counterfeit respirators found below.
  • If your respirator is counterfeit, stop using it as it may not protect you against the virus that causes COVID-19.
  • Report any health product adverse events or complaints to Health Canada.
  • Provincial and territorial health authorities and healthcare institutions should review their inventories of respirators to confirm that they meet the Government of Canada technical specifications for healthcare settings for the COVID-19 response.

Media enquiries

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

Public enquiries

613-957-2991
1-866-225-0709
hcinfo.infosc@canada.ca