Health Canada1 Jun 2026
Omnipod® Insulin Management System - Omnipod®
Health Canada published a recall notice for Omnipod® Insulin Management System - Omnipod® on 1 Jun 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 1 Jun 2026
- Recall type
- Health product recall
- Companies
- Insulet Corporation · 100 Nagog Park, Acton, Massachusetts, United States, 01720
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
Issue: 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. Additional information Details Original published date: 2026-05-29 Affected products: Affected products Lot or serial number Model or catalogue number Omnipod® Insulin Management System - Omnipod® L72521 ZXR420 Omnipod® Insulin Management System - Omnipod® L72516 POD-ZXR425 Omnipod® 5 Automated Insulin Delivery System 10-Pack Pods PH1U01222522 POD-OMNI-I1-6729 Omnipod® DASH® More than 10 numbers, contact manufacturer. POD-BLE-C1-520 Omnipod® DASH®, Pods 10-Pack More than 10 numbers, contact manufacturer. POD-BLE-C1-529 Omnipod® 5 Pod PH1U01222522 POD-OMNI-I1-6720 Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.