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Issue: Unauthorised device
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Last updated: 2022
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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 - 12 of 12 items.
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
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 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
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
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
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
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
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
Ai Face Recognition Screening Machine
Imported an unlicensed class II medical device.
Recall start date: Nov 1, 2021
RecallHealth product recall | 2022-02-08
Cara V4
Potential violation of the rules and regulations related to market approval of some features of the software medical device Cara based on artificial intelligence.
Recall start date: Jan 11, 2022
RecallHealth product recall | 2022-01-24
Medpor Titan Orbital Floor And Wall (Mtb)
On November 22, 2021 via customer complaint - Stryker became aware the inside the packaging of one reported item #81032 (Titan OFW-MTB, right) a non-conforming product was found. Contrary to the design, the barrier layer was manufactured…
RecallHealth product recall | 2022-01-01
Veriseq Pgs Kit
The Veriseq PGS kit was distributed in Canada without a valid class III medical device license.
Recall start date: 2021-12-17
RecallHealth product recall | 2022-01-01