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Please note: using the search filters may not provide accurate search results for records prior to November 2021. When searching for older records, please ensure that you use the include archive checkbox.

Displaying 1 - 15 of 22 items.

Health alert or recall Fingertip Pulse Oximeter
Voluntary recall-interim order authorisation not approved. Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Infrared Thermometer
Voluntary recall-interim order authorization not approved.  Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall Digital Thermometer
Voluntary recall- interim order authorisation not approved. Recall start date: December 2, 2021
RecallHealth product recall | 2022-06-27
Health alert or recall KN95/FFP2 Particulate Respirator Mask - Model 516W
Unauthorized KN95/FFP2  particulate respirator mask - do not use as a respirator.  Recall start date: May 10, 2022
RecallHealth product recall | 2022-06-07
Health alert or recall Cortrak 2 Enteral Access System
The recall is being conducted due to information received from Health Canada, that the device which was classified by Avanos Medical as a class 1 medical device, should be reclassified in a higher medical device class. Higher…
RecallHealth product recall | 2022-06-07
Health alert or recall Surestrips Rapid Response Covid-19 Antigen Rapid Test Device
Surestrips Rapid Response Covid-19 Antigen Rapid Test Device are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e.…
RecallHealth product recall | 2022-05-30
Health alert or recall Surestrips Covid-19 Antigen Test
Surestrips Covid-19 Antigen Tests are not authorized for sale in Canada as they were re-packaged into single tests and re-labelled without authorization by the manufacturers listed on the label (i.e. Artron Laboratories Inc.).  Recall start date…
RecallHealth product recall | 2022-05-30
Health alert or recall Health Canada reminds Canadians that plasma pens are unauthorized and may pose health risks, following complaints involving Calgary and North York spas
August 25, 2019 For immediate release OTTAWA – Health Canada is reminding Canadians that plasma pens are not authorized for sale in Canada and that these devices may pose health risks. Health Canada is also underlining that consumers should be wary…
AlertInformation update | 2022-05-11
Health alert or recall Plasma pens are not authorized in Canada and may pose health risks
November 26, 2018 For immediate release OTTAWA – Health Canada is advising consumers that plasma pens (also known as “fibroblast” devices) promoted for cosmetic skin treatments such as eyelid lifts, wrinkle reduction and…
AlertInformation update | 2022-05-11
Health alert or recall Ultrasonic Gastrovideoscope
Olympus Medical Systems Corp (OMSC) conducted a postmarket risk assessment of the GFUC140P-AL5. As part of that review, OMSC applied updated FDA guidance for reprocessing validation. OMSC's testing showed that the GF-UC140P-AL5, when reprocessed in the…
RecallHealth product recall | 2022-04-04
Health alert or recall Mani Diamond Tomita-Saw
The manufacturer, a third-party supplier (Mani, Inc.), discontinued production of the Mani™ Diamond Tomita-Saw™ product and subsequently terminated the medical device license for this device. Recall start date: Nov 24, 2021
RecallHealth product recall | 2022-03-28
Health alert or recall Architect "I" System - Stat Myoglobin Assay
The purpose of this recall is to inform the customer of a product recall for architect stat myoglobin calibrators, ln 2k43-01, lot number 166000. They have identified that this calibrator lot did not meet acceptance criteria during ongoing stability…
RecallHealth product recall | 2022-03-14
Health alert or recall Restore Wound Cleanser
The product license is on hold/suspended due to the missing MDSAP certification from the supplier Biomed. Since there is no MDSAP certification the products are not meeting the regulatory requirements of the act or MDR for Health Canada (Medical Devices…
RecallHealth product recall | 2022-03-14
Health alert or recall Bd Alaris
Recall is being initiated to notify customers to the risk of the use and installation of unauthorized, third-party parts on the Alaris system. Recall start date: Feb 7, 2022
RecallHealth product recall | 2022-02-28
Health alert or recall Ai Face Recognition Screening Machine
Imported an unlicensed class II medical device. Recall start date: Nov 1, 2021
RecallHealth product recall | 2022-02-08
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