Medical Device Respirator recalls

Starting date:
May 10, 2020
Posting date:
June 23, 2020
Type of communication:
Information Update
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Important Safety Information, Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73137

Last updated:

Summary

  • Product: Certain respirators, including KN95 Filtering Facepiece Respirators (“respirators”).
  • Issue: Not all respirators meet the minimum 95% filtration rate required.
  • What to do: Do not use the masks on the following list in situations where a minimum 95% filtration rate is required (such as health care settings).

Reason

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).

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. The products are not being removed from the market.

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.

Learn more about respirators that are approved under standards used in other countries that are similar to NIOSH-approved N95 respirators.

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.

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.

Affected products
Manufacturer Device Name/Model Distributor/Importer Date Added
AAB (China) Co. Ltd. KN95 Protective Breathing Mask n/a n/a
Anhui Baishidun Protective Equipment Co., Ltd. Baishidun FFP2 n/a n/a
Anhui Jinling Plastics Co., Ltd. UNKNOWN n/a n/a
Anhui Kangweijia Labor Protection Articles Co., Ltd. 9501 Protective Mask n/a n/a
Anhui Meihu Medical Supplies Technology Co., Ltd. KN95 Steroscopic Protective Mask n/a n/a
Anhui RYZUR Medical Equipment Manufacturing Co., Ltd. KN95B n/a n/a
An Hui Su Bo Lun Clothing Co., Ltd. SU KN95 n/a n/a
Anhui Subolun Garment Co. Ltd ASG KN95 n/a n/a
Anhui Subolun Garment Co. Ltd Subolun n/a n/a
Anhui Subolun Garment Co. Ltd KN95 n/a n/a
Anshun Health & Medical Technology Co., Ltd. AKF2002 n/a n/a
BiotechInnova TechnoWeb N95 Surgical Mask n/a n/a
Beijing Ruishan Bozhong Medical Instrument Co., Ltd. RZ95B n/a n/a
Bengbu Hongjie Medical Equipment Co Ltd HJ-003 KN95 n/a n/a
Bengbu Hongjie Medical Equipment Co Ltd QHR KN95 n/a n/a
Changning Lingjiakang Protective Products Factory KN95 Stereo Protective Mask n/a n/a
Chuzhou Qiaodong Industrial Co., Ltd. Langie KN95 Respirator n/a n/a
CTT Co., Ltd. KN95 (8410) n/a n/a
CTT Co., Ltd. KN95 Respirator Mask n/a n/a
Daddybaby Co., Ltd. KN95 4-PLY n/a n/a
Delta Plus CA 38.504 n/a n/a
Dongguan HuaGang Communication Technology Co., Ltd. KN95 Disposable Face Mask Oakmont Holdings Ltd. 2020-05-31
Dongguan Liangji Technology Development Co., Ltd. KN95 Mask n/a n/a
Dongguan Mau Gee Industrial Ltd. KN95 Disposable Face Mask n/a n/a
Dongguan Oukangda Medical Technology Co., Ltd. Self-Priming Filter Respirator n/a n/a
Dongguan Oukangda Medical Technology Co., Ltd. Kangerda KN95 Particulate Respirator Innoline Inc 2020-05-13
Dongguan Tian Ren He Yi intelligent Co., LTD KN95 Mask Innoline Inc 2020-05-13
Dongguan Weicon Medical Equipment Technology Co., Ltd. KN95 Mask n/a n/a
Dongguan Xianda Medical Equipment Co., Ltd. Tomson Newt KN95 Protective Mask 1862505 Ontario Inc. dba BF Medical Canada 2020-05-19
Solutions 2 Go Inc. 2020-05-12
Stanfield's Ltd. 2020-05-20
Donnaturel; Wanwei Chuangda Medical Technology (Shandong) Co Ltd Respirator n/a n/a
Dongguan Wei Sheng Medical Technology Co., Ltd. KN95 n/a n/a
E-POWER LIMITED SHENZHEN 9500 n/a n/a
Flyhorse Industrial Co., Ltd. FL 0616 n/a n/a
Foshan Jintailang Trading Co., Ltd. RD-KN95-01 n/a n/a
Fujian Jimei Household Products Co., Ltd. Disposable KN95 Mask n/a n/a
Fujian Little Forest Technology Co., Ltd. Protective Mask n/a n/a
Fujian Pageone Garments Co., Ltd. KN95 Protective Mask (Non-Medical) Natural Trade Ltd 2020-06-16
F&W Certification Co., Ltd. N95 n/a n/a
Gaomi Chenheng Labor Protection Supplies Co., Ltd. Kn95 n/a n/a
Garry Galaxy Biotechnology Co., Ltd. Respirator Mask With TruTone Technology n/a n/a
Global Safety First ReadiMask n/a n/a
Guangdong Fei Fan Mstar Technology LTD Purvigor KN95 n/a n/a
Guangdong Jiangmen Huayue Industrial Co. Ltd. Three-Dimensional Protective Respirator (disposable respirator) n/a n/a
Guangdong Kangju Medicine Science Co. KJ-L n/a n/a
Guangdong Kaper Protection Technology Co., Ltd. KP-K02 W/T Valve n/a n/a
Guangzhou Meisu Industry Co., Ltd. MS-KN95-01 n/a n/a
Guangdong Nafei Industrial Holding Co., Ltd. Efficient Nursing Protective Mask n/a n/a
Guangdong Nafei Industrial Holding Co., Ltd. NAFY Protective Mask n/a n/a
Guangdong Nuokang Medical Technology Co., Ltd. KN95-Certified Particulate Respirator n/a n/a
Guangdong Qian Jing Testing Co., LTD. DNW Protective Mask n/a n/a
Guangdong Shantou Haimeisi Clothing Co., LTD Self Suction Filter Particle Respirator n/a n/a
Guangdong Shantou Machinery KN95 Mask n/a n/a
Guangdong Zhizhen Biological Medicine Co., Ltd. KN95 Three-Dimensional Protective Respirator n/a n/a
Guangdong Zhizhen Biological Medicine Co., Ltd. Industrial Protective Face Mask n/a n/a
Guangzhou Aiyinmei Co., Ltd. AYM-KN95 n/a n/a
Guangzhou Aiyinmei Co., Ltd. A&F KN95 n/a n/a
Guangzhou Aomy Biomedical Technology Co., Ltd. Modèle AMO-267 n/a n/a
Guangzhou Folunsi Industrial Co., Ltd. Civil Mask n/a n/a
Guangzhou Folunsi Industrial Co., Ltd. Subolun n/a n/a
Guangzhou Huashan Biotechnology Co., Ltd. GF-Mask KN95 Mask n/a n/a
Guangzhou Kangbang Medical Equipment Co., Ltd. KN95 Mask n/a n/a
Guangzhou Kangling Medical Supplies Co., Ltd. KN95 Protective Face Masks n/a n/a
Guangzhou Nan Qi Xing Nonwoven Co., Ltd KN95 Respirators Natural Trade Ltd 2020-06-16
Guangzhou Powecom Labor Insurance Supplies Co., Ltd. Powecom KN95 Protective Mask FudakinLED Lighting Ltd. 2020-05-27
FYi Doctors Eye Care Services 2020-05-26
Guangzhou Suiji Biotechnology Co., Ltd. KN95 Three-Dimensional Protective Respirator 1848679 Alberta Ltd 2020-07-13
Guangzhou Sunjoy Auto Supplies Co., Ltd. SUNJOY K1 n/a n/a
Guangzhou Sunjoy Auto Supplies Co., Ltd. K1 Self Suction Filter Respirator n/a n/a
Guangzhou Tianyi Zhongliang Biotechnology Group Co., Ltd. KN95 Disposable Protective Mask n/a n/a
Guanyang Yuhan Textile Co., Ltd. KN95 Protective Face Mask n/a n/a
Guizhou Bocai Medical Equipment Co., Ltd. KN95 Respiratory Protective Mask n/a n/a
Hangzhou Senrunqing Technology Co., Ltd. KN95 Mask-C n/a n/a
Hangzhou Unibear Medical Deveices Co. Ltd. HUMD KN95 n/a n/a
Hangzhou Unibear Medical Deveices Co. Ltd. UBMD 2020-01 KN95 n/a n/a
Hangzhou Unibear Medical Deveices Co. Ltd. UNIBEAR n/a n/a
Henan Fengzihihuang Industrial Co., Ltd. HF/KN95-3 n/a n/a
Henan Kang Medical Devices Co., Ltd. KN95 Protective Mask - KS16 n/a n/a
Henan Lita Textile Technology Co., Ltd. KN95 Protective Mask n/a n/a
Huabai 9501 n/a n/a
Huizhou Huinuo Technology Co., Ltd. HV-N 9501B (Non-Sterile Mask) n/a n/a
Huizhou Huinuo Technology Co., Ltd. HV-N White KN95 n/a n/a
Huizhou Jiahe Cube Technology Co., Ltd. KN95 Protective Mask (Non-Medical) n/a n/a
Huizhou Zhongna Medical Technology Co., Ltd Anysound KN95 Self-Priming Filter & Anti-Particle Respirator n/a n/a
Hunan Royal Crown Medical Products Co., Ltd. KN95 Mask n/a n/a
H&Y Industrial Ltd. KN95 Mask n/a n/a
Jiangmen Huadizhiguang Lighting Co., Ltd. KN95 Protective Mask n/a n/a
Jiangsu Jiton Clothing Corporation JT-KN95 Reusable and Sterilizable Nano-mask KN95 n/a n/a
Jiangsu Newborn Medical Technology Co., Ltd. Protective Mask KN95 n/a n/a
Jiangsu Weichuangli New Materials Co., Ltd. Pulsar PMN9520 (WCL-0075) n/a n/a
Jiangxi Hornet Industrial Co., Ltd. #S-KN95 n/a n/a
Jiangxi Yifengyuan Biological Engineering CO., Ltd. KN95 FFP2 Disposable Protective Mask n/a n/a
Jinhua Jiadaifu Medical Supplies Co., Ltd. KN95 Face Mask (Non-Medical) n/a n/a
Jinhua Jinchuang Labor Protection Tools Factory KN95 n/a n/a
Jinhua Jingdi Medical Supplies Co., Ltd. Disposable Face Mask n/a n/a
Jining Jianda Medical Device Technology Co., Ltd. PM2.5 KN95 n/a n/a
Kindly Care Products Co., Ltd. Y-9500 Jheeta Medical Corp. 2020-05-20
King Year and Packaging Co., Ltd. Self-Breathing Filtration Particle-Preventive Respirator n/a n/a
King Year and Packaging Co., Ltd. Self-Breathing Filtration Particle-Preventive Respirator n/a n/a
KMP Yikangyuan n/a n/a
Kuangye (Dongguan) Technology Co., Ltd. Geyou KN95 Environmental Protective Respirator n/a n/a
Lamdown SD-KN95 1308072 Ontario Inc. O/A HPU Medical Wholesale 2020-05-20
2727056 Canada Inc 2020-05-12
Lanshan Shendun Technology Co., Ltd. SD-KN95 213 Advisory Inc. 2020-06-08
LitezAll Wanning Protective Mask n/a n/a
Luoyang Haoyang Clothing LTD Respirator n/a n/a
Mezorrison Health Science & Technology (shenzhen) Co., Ltd. MZC-KZ-06 n/a n/a
Nanjing Sunny Technology Co., Ltd. Disposable Face Mask n/a n/a
Nantong Gold-Sufang Weaving Co. Ltd. KN95 Face Mask n/a n/a
Ningbo Green Health Science & Technology Co., Ltd. KN95 Protective Mask n/a n/a
Ningbo Green Health Science & Technology Co., Ltd. Disposable Protective Mask (Non-Medical) n/a n/a
Ningbo Kangqi Medical Supplies Co. Ltd. Civil Mask n/a n/a
Ningbo Kangqi Medical Supplies Co. Ltd. KN95 n/a n/a
Ningbo Kangqi Medical Supplies Co. Ltd. NKMS KN95 n/a n/a
Ningbo YiXin Intelligentized Science and Technology Co. Ltd. KN95 (Non-medical) CTG Brands Inc. 2020-05-20
Ningbo Yixin Intelligent Technology Co., Ltd. Disposable Face Mask n/a n/a
Promier Products Protective Mask n/a n/a
Purvigor KN95 Antibacterial Mask n/a n/a
Putian City Puxin Medical Technology Co. Disposable Mask for Civil Use n/a n/a
Qingdao Caiyang Childrens Articles Co.Ltd QCCA 2020-01 KN95 Bioaspect Inc. 2020-06-24
Qingdao Hongshunyi Project Co., Ltd(ICK) Respirator n/a n/a
Qingdao Miuton Medical Co., Ltd. N95 Protective Mask n/a n/a
Qingdao Orphila Medical Technology Co., Ltd. OM-KN95-FFP2 n/a n/a
Quzhou Benneng Vehicle Co. Ltd. QBV 2020-01 KN95 n/a n/a
Quzhou Benneng Vehicle Co. Ltd. Self-suction Filter Respirator n/a n/a
San Jiao JS95-01 n/a n/a
Sanjiao Oral Health Co., Ltd. KN95 Daily Protective Face Mask FudakinLED Lighting Ltd. 2020-05-27
Senke Pharmaceutical (Chengdu) Co., Ltd. KN95 Non-Powered Air-Purifying Particulate Respirator n/a n/a
Shandong Haidike Medical Products Co., Ltd. Medical Protective Mask - Folding Type n/a n/a
Shanghai Kindly Medical Instruments Automation Research Center Co., Ltd. KN95 Face Mask n/a n/a
Shenzhen Crawford Technology Co., Ltd. XO-01 n/a n/a
Shenzhen Crawford Technology Co., Ltd. XO-03 n/a n/a
Shenzhen FITTOP Health Technology Co., Ltd. FM80 n/a n/a
Shenzhen Hangsen Star Technology Co., Ltd. Alchemy KN95 Face Mask A1 n/a n/a
Shenzhen Meili Medical Devices Co., Ltd. KN95 Protective Mask n/a n/a
Shenzhen Jiameilantai Industrial Co., Ltd. Face Mask Pro Aide Medic Inc 2020-05-12
Shenzhen Mingjiang Medical Supplies Development Co., Ltd. KN95 Multiple Layer Protective Mask n/a n/a
Shenzhen Missadola Technology Co., Ltd. (1AK Medical Supplies) Model 2626-1 2105522 Ontario Ltd. 2020-07-15
Shenzhen Ruichen Technology Co. LTD RC-95-001 n/a n/a
Shenzhen Sanai Medical Devices Group Co., Ltd. Disposable Protective Mask n/a n/a
Sichuan Fogu Medical Technology Co Ltd Respirator n/a n/a
Sinpul Health (Shenzhen) Co., Ltd. Face Mask KN95 n/a n/a
Tianjin Benmo Medical Equipment Co., Ltd. ONO KN95 Folding Protective Mask Canada Integrated Health Solutions 2020-06-17
Tongcheng Chengfeng Protective Equipment Co., Ltd. Wanhuizhong Anti-Dust Respirator n/a n/a
Tongcheng Jieli Labor Protection Products Co., Ltd. Disposable Earloop Style Mask n/a n/a
Toptec Co., Ltd. Air Queen Nano Mask n/a n/a
Wenzhou Meiyi Medical Device Co., Ltd. MY-002 n/a n/a
Wonder Medical Technology Co., Ltd(DONNATUREL) WMT KN95 n/a n/a
Xinsilu Science & Technology Co., Ltd. Earhook KN95 n/a n/a
Yiwu Henghao Household Products Co., Ltd. HH-KN95-001 n/a n/a
Yiwu Qixun Scientific Co., Ltd. Qixun KN95 Mask n/a n/a
Yiwu Wells Knitting Co. Ltd. Respirator n/a n/a
Yiwu Yifan Knitting Co., Ltd. KN95 (LSK2020-2) n/a n/a
Yongkang Promise Import Export KN95 Particle
Respirators
Nu-life Medical & Surgical Supplies Inc. 2020-06-16
Yufing (Guangdong) Lighting Technology Co., Ltd. 9001V KN95 Earloop Type n/a n/a
ZhangJiaGang ShineYa Sanitary Products Co., Ltd. XY-FM01 n/a n/a
Zhangzhou Easepal Industrial Co., Ltd. Homedics KN95 Protective Respirator Mask n/a n/a
Zhejiang Kanghao Medical Instruments Co., Ltd. KN95 Respirator n/a n/a
Zhejiang Baiyi Intelligent Garment Co., Ltd. KN95 Respiratory Protection n/a n/a
Zhejiang Beilan Protective Equipment Co. Ltd. KN95 n/a n/a
Zhejiang Shengtai Baby Products Co., Ltd. KN95 Ear Loop n/a n/a
Zhongshan Cassiey Biotechnology Co., Ltd. N95 Masks + Particulate Protection Respirator n/a n/a
Zhongshan Qiangou Protective Equipment Technology Co., Ltd. KN95 Protective Mask n/a n/a
Zhongshan Siyuan Electric Co., LTD k003-2 n/a n/a
Zhongshan Zhongxin Medical Technology Co., Ltd. Protective Mask n/a n/a
Zhejiang Allta Industrial Co., LTD ALLTA Respirator 9591 2743512 Ontario Ltd. O/A Sentry Spill Control 2020-05-14
Medtech Canada Medical Supplies Ltd 2020-05-15
MEP Brothers Ltd 2020-05-14