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KN95 respirators recall

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Health Canada has determined that KN95 Filtering Facepiece Respirators (“respirators”) which have failed to demonstrate a 95% filtration rate and are possibly being imported into Canada, pose a health and safety risk to users.

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Important safety information for certain respirator masks

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Health Canada is committed to ensuring that the medical devices available to Canadians meet the necessary safety and effectiveness standards. The Department has contactedcompanies 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.

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Cybersecurity vulnerabilities associated with some medical devices with Bluetooth Low Energy chips

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OTTAWA– Health Canada is informing Canadians, healthcare professionals, and manufacturers about a series of cybersecurity vulnerabilities named “SweynTooth”. These vulnerabilities may affect devices using the Bluetooth Low Energy (BLE) protocol. Because of these vulnerabilities, some medical devices that use BLE chips could be at risk of a cyber attack. Affected medical devices may include pacemakers, blood glucose monitors, ultrasound systems and insulin pumps.

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Needle-free dermal filler devices used for cosmetic skin treatments are not authorized in Canada and may pose health risks

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OTTAWA – Health Canada is advising Canadians that needle-free dermal filler devices that are promoted for cosmetic skin treatments—such as reducing wrinkles and increasing lip volume—may pose health risks. These small handheld medical devices used to deposit hyaluronic acid or other dermal fillers under the skin are also known as hyaluron pens, hyapens, fog injection devices, SERA pens, and nebulizer injector guns.