MedTech Current regulatory intelligence and device recall publications for Canada.
Health Canada has classified the recall of Philips Lumify portable ultrasound systems as Type I after software-related transducer re-registration failures and unstable USB connections were found to prevent or interrupt scanning and delay patient care.
Health Canada has classified the recall of 10 specified Abiomed Automated Impella Controllers as Type I after a retrospective review found that the affected consoles had not received FCN 113 updates intended to prevent screen freezing and false controller errors during the Purge Cassette Change Wizard.
Canada's September 2026 Domestic Substances List orders add the P flag to 204 polymer identifiers previously assessed as reduced regulatory requirement polymers. The final order covers fewer entries than the 220 proposed in February; suppliers and device manufacturers should confirm that the polymer form supplied still meets the RRR criteria.
Canada has added CAS 68910-05-4 to the Domestic Substances List after completing its new-substance assessment, while retaining Significant New Activity requirements for defined consumer-product and cosmetic uses. The order does not create a general medical-device restriction, but it is relevant upstream materials intelligence where this substance appears in Canadian supply chains.
Canada has amended its cross-border hazardous-waste and hazardous-recyclable-material rules to clarify that required export permits must be in place before a shipment begins moving, refine waste-related provisions, and prepare for implementation of the Basel Ban Amendment. The new export prohibition to non-Annex VII countries has a separate delayed commencement tied to Canada's ratification of the Ban Amendment.