Authorized medical devices for uses related to COVID-19: List of products no longer authorized under IO

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What is included in this list

Authorizations may be revoked for some medical devices that were authorized under the:

New devices may be added to this list as required.

It is important for health care professionals and other users to check this list regularly for those products no longer authorized.

Reasons for authorization being removed

There are 5 reasons for removing authorization under (IO) No. 3:

  1. The risks outweigh the benefits.
  2. The terms and conditions were not met.
  3. A foreign regulatory authority cancelled its authorization.
  4. The manufacturer received a medical device licence.
  5. The manufacturer is no longer marketing the device.

Risks outweigh benefits

Under paragraph 8(a) of IO No. 3, the Minister may cancel a device's authorization if there is enough evidence showing:

Terms and conditions not met

Under paragraph 8(b) of IO No. 3, the Minister may cancel a device's authorization if the terms and conditions placed on the authorization are not being met.

Authorization cancelled by a foreign regulatory authority

Under paragraph 8(d) of IO No. 3, the Minister may cancel a device's authorization if the foreign regulatory authority has cancelled or suspended the authorization for sale. Foreign regulatory authorities include the U.S. Food and Drug Administration, the Australian Therapeutic Goods Administration and others.

Licence issued

Under paragraph 8(c) of IO No. 3, the Minister may cancel a device's authorization if the manufacturer has received a medical device licence under the Medical Devices Regulations. The licence confirms that the device continues to meet regulatory requirements and is safe for people to use.

Marketing has ceased

The manufacturer has asked Health Canada to cancel the authorization because the manufacturer is no longer selling the device in Canada.

Non-compliance with a request for additional information

Under section 9, the Minister may cancel an authorization if Health Canada has sent the manufacturer a request for:

List of Covid-19 Medical Devices No Longer Authorized
Device name Manufacturer IO authorization number Date the notice of cancellation was issued Reason for cancellation
One Health Medical Technologies Emergency Use Ventilator One Health Medical Technologies INC. 316070 2022-06-16 The manufacturer is no longer marketing the device.
Protective Face Shield Steer Medical Inc. 314254 2022-05-31 The manufacturer is no longer marketing the device
Commercial N95 Respirator InnoLifeCare 327717 2022-05-27 The manufacturer is no longer marketing the device
Procedure Earloop Face Masks Zik Global Inc O/A Canadian Health Masks 320588 2022-05-06 The manufacturer is no longer marketing the device
Surgical N95 Respirator InnoLifeCare 327716 2022-05-06 Marketing has ceased
Bip Endotracheal Tube Evac Bactiguard AB 316728 2021-11-04 Licence Issued
Bip Endotracheal Tube Bactiguard AB 316729 2021-11-04 Licence Issued
Bip Foley Tempsensor Bactiguard AB 320967 2021-11-04 Licence Issued
Kn95 medical protective masks Shanghai Xiangsheng Trade Co., Ltd 312838 2021-10-29 Risks outweigh benefits
KN 95 Protective Mask New Zhong Yang Technology (Shenzhen) Co. 314410 2021-10-29 Risks outweigh benefits
Medical Surgical Mask Hehan Yadu Industrial Co., Ltd 312807 2021-09-14 The risks outweigh the benefits
3 Ply Face Mask with Flat Earloop Wuhan Morntrip Trading Co., Ttd 312809 2021-09-14 The risks outweigh the benefits
Mask Xinxiang City Hongda Medical Material Limited Company 312811 2021-09-14 The risks outweigh the benefits
Daily Protective Face Mask Mingshi Technology Co. LTD 313113 2021-09-14 The risks outweigh the benefits
Disposable Face Mask Violet Home Textile Technology Co., Ltd 313486 2021-09-14 The risks outweigh the benefits
Face Mask Guangdong Owgels Science & Technology Co., Ltd 313487 2021-09-14 The risks outweigh the benefits
N95 Particulate Respirator Shanghai Dasheng Health Products Manufacture Co., LTD. 321706 2021-08-26 A foreign regulatory authority cancelled its authorization.
Synguard nitrile exam gloves This cancellation only affects devices imported by Riell Inc that are labelled to be manufactured by Shandong INTCO Medical Products co., Ltd. (China) 314820 2021-08-06 The manufacturer is no longer marketing the device.
MEDICAL VINYL EXAMINATION GLOVES ZIBO INTCO MEDICAL PRODUCTS CO., LTD. 313104 2021-07-28 The manufacturer is no longer marketing the device.
ATB Disposable Face Mask Zhongshan ATB Medical Technology Company Limited 314835 2021-07-06 The manufacturer is no longer marketing the device in Canada
Spartan Cube Covid-19 System Spartan Bioscience Inc. (Canada) 313012 2021-01-22 Terms and Conditions Were Not Met
Ventilator Battery Interstate All Battery 314497 2020-10-16 Licence Issued
Kn95 Non-powered Air Purifying Particle Respirator Senke Pharmaceutical (Chengdu) Co., Ltd 313083 2020-05-08 Risks Outweigh Benefits
Dtc3x N95 Particulate Respirator Shanghai Dasheng Health Products Manufacture Co., Ltd. 314322 2020-06-17 Risks Outweigh Benefits
Respirator Disposable Face Mask (Kn95) Groupe Ricochet Inc. 312817 2020-06-23 Risks Outweigh Benefits
Mapleswab Swabs Shapetry Labs Inc. 314196 2020-06-30 Risks Outweigh Benefits
Protective Respirator (N95 Masks) Hunan Triplex Precision Medical Devices Co. Ltd 313261 2020-08-20 Risks Outweigh Benefits
Nitrile Power Free Examination Gloves This Cancellation Only Affects Devices Imported by Shanghai Lansheng Light Industrial Products Imp. & Exp. Corp., Ltd That Are Labelled to Be Manufactured by Hartalega Sdn. Bhd. (Malaysia) 313909 2021-05-18 Risks Outweigh Benefits
Technologist Choice Nitrile Medical Examination Gloves Bio Nuclear Diagnostics Inc. 314317 2021-06-02 The manufacturer is no longer marketing the device.
Face Mask Wuhan Aimmax Trade Co, Ltd. 312810 2021-06-02 The manufacturer is no longer marketing the device.
Singclean Disposable Medical Mask Hangzhou Singclean Medical Products, Ltd. 313477 2021-06-03 The manufacturer is no longer marketing the device.
Granville Swab Nasopharyngeal Specimen Collection Device Granville Biomedical Inc. 319269 2021-09-20 Terms and conditions not met
Biofire COVID-19 Test Biofire Defense (United States) 314097 2022-04-26 The manufacturer is no longer marketing the device.
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