Guangdong Nuokang Medical Technology Co., Ltd. Guangdong Nafei Industrial Holding Co., Ltd.
Guangdong Kaper Protection Technology Co., Ltd. Three-Dimensional Protective Respirator (disposable respirator) Gaomi Chenheng Labor Protection Supplies Co., Ltd. dba BF Medical Canadaĭonnaturel Wanwei Chuangda Medical Technology (Shandong) Co Ltdĭongguan Wei Sheng Medical Technology Co., Ltd.įujian Jimei Household Products Co., Ltd.įujian Little Forest Technology Co., Ltd.įujian Sunkinetic Smart Technology Co., Ltd. This table is a summary of the products Health Canada has asked companies to voluntarily recall/relabel, along with any associated distributors or importers who have confirmed to be importing or distributing the products in Canada and have initiated a recall under section 64 of the Medical Device Regulations.Īnhui Baishidun Protective Equipment Co., Ltd.Īnhui Kangweijia Labor Protection Articles Co., Ltd.Īnhui Meihu Medical Supplies Technology Co., Ltd.Īnshun Health & Medical Technology Co., Ltd.Ĭhangning Lingjiakang Protective Products Factoryĭongguan HuaGang Communication Technology Co., Ltd.ĭongguan Liangji Technology Development Co., Ltd.ĭongguan Oukangda Medical Technology Co., Ltd.ĭongguan Tian Ren He Yi intelligent Co., LTDĭongguan Weicon Medical Equipment Technology Co., Ltd.ĭongguan Xianda Medical Equipment Co., Ltd.ġ862505 Ontario Inc. The content on this webpage and the table below will be updated on a regular basis as Health Canada obtains new information related to this recall. Learn more about respirators that are approved under standards used in other countries that are similar to NIOSH-approved N95 respirators. In Canada, re-labelling of a medical device that fails to conform to claims relating to its effectiveness is considered a recall in accordance with the Medical Devices Regulations. The products are not being removed from the market. Health Canada has asked importers and distributors that have imported respirators that do not meet performance standards to notify their customers and re-label 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. Based on the testing conducted by the National Institute of Occupational Safety and Health (NIOSH) National Personal Protective Technology Laboratory (NPPTL), and other laboratories, Health Canada has determined that certain respirators that do not meet performance standards may pose a health and safety risk to users when used in a setting that requires 95% filtration (such as a health care settings).
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