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Omnipod® Insulin Management System - Omnipod® — recall 82140

Health Canada — Medical Devices · Canada · 2026-06-01 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
82140
Date of alert
2026-06-01
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
General hospital and personal use - Gastroenterology and urology
Product type
Medical devices
Reported risk: The defect is related to tears on the external (exposed) soft cannula. The defect is consistently located near the bottom housing window, with similar physical appearance and tear orientation across devices. The cannula tear may result in a compromised fluid path due to damage to the cannula, leading to potential reduced or interrupted insulin delivery. If insulin is not delivered properly, user may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated. To identify the impacted product and lot number, users will be asked to review the notification letter and follow the instructions: Discontinue use of any impacted pod immediately. If the pod the user is currently using, is from an affected lot, it is important that the user immediately changes the pod to resume insulin delivery. When changing the pod, confirm that the new pod is not from an affected lot.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/omnipodr-insulin-management-sy

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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