May 11, 2020

Health Canada Alert: Important safety information for respirator masks

Health Canada is committed to ensuring that the medical devices available to Canadians meet the necessary safety and effectiveness standards. The Department has contacted companies that may be importing or distributing certain respirators, including KN95 respirators, that may not meet expected performance standards in Canada to request that they stop sale and relabel the products as face masks instead of respirators.

This follows the recent U.S. Food and Drug Administration (FDA) communication regarding concerns that certain filtering facepiece respirators from China may not provide consistent and adequate respiratory protection based on testing conducted by the National Institute for Occupational Safety and Health (NIOSH) - National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC).

Health Canada has asked importers and distributors that may have imported respirators that do not meet performance standards to notify their customers and relabel products to indicate that while these masks may not meet the standards required for frontline healthcare workers, they could be used as face masks in settings where a 95% filtration is not needed. The products are not being removed from the market.