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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…

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…

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

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…

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…

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

Imported an unlicensed class II medical device. Recall start date: Nov 1, 2021

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

The Veriseq PGS kit was distributed in Canada without a valid class III medical device license. Recall start date: 2021-12-17

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…

According to the October 6 correspondence from Health Canada, KN95 masks may not meet the requirements defined by standard GB2626-2006. Recall start date: Nov 16, 2021

The centrifuge is advertised with a PRP indication which classifies it as a class II medical device in Canada. The Elite Centrifuge does not have a class II licence, and therefore is not authorized for sale in Canada. Recall start date: Nov 29, 2021

The manufacturer distributed the centrifuges 642 VFD plus in canada contain PRP references in the manual, front panel and on the device labeling. The Canadian authorities indicated that the issue needs to be revised for a class I standard. Recall…

The manufacturer confirmed that some SARS-COV-2  Rapid Antigen Test Nasal kits lots were erroneously distributed with Medico swabs, which are not included in the current Health Canada interim order authorization for that kit.…