It says some batches of Nova Max Blood Glucose Test Strips may give an erroneous reading because they were contaminated during manufacturing.
The department says the affected test strips could produce a false blood sugar reading that makes it seem like the user's blood glucose level is abnormally high.
Health Canada says people could give themselves the wrong dose of insulin based on the readings produced by the faulty strips.
The voluntary recall also affects unused Nova Max Plus Glucose Meter Kits, which contain test strips from the recalled lots.
The test strips are sold in retail stores and pharmacies and online; they may be used in health-care facilities.
The department says people using strips from the recalled lots should stop immediately and find another way to monitor their blood sugar.
The Canadian distributor, Nova Biomedical Canada Ltd., is providing guidance for customers. People affected by the recall can also consult their health-care professional if they have concerns, Health Canada says.
A list of the batches that are being recalled can be seen on the Health Canada website at: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34883a-eng.php