Published: 27 May, 2026 Insulet has issued a critical recall for specific lots of Omnipod 5 and Omnipod DASH Pods following identification of a manufacturing issue through routine product monitoring. The issue relates to a small tear that may occur in the Pod’s tubing (cannula), just above the skin and between the Pod and the point where the cannula enters the body. If this happens, insulin may leak outside the Pod instead of being fully delivered into the body. This can result in less insulin being delivered than expected. Some people may notice signs such as dampness on the skin or Pod adhesive, or a smell of insulin. However, in some cases, leaks may be difficult to detect. As a result, blood glucose levels may rise and may not respond as expected to insulin delivery. In Omnipod 5 Automated Mode, an alert may be triggered, but this issue can also occur without any alert. It is important not to rely solely on Pod alerts to identify a problem. Affected lots include: Omnipod® 5: PH1U10212421 Omnipod DASH®: PD1U09042421, PD1U11122421, PD1U11202421 If insulin delivery is reduced, there is a risk of high blood glucose levels (hyperglycaemia). In severe cases, this may lead to diabetic ketoacidosis (DKA), a serious condition requiring urgent medical treatment. Globally, there have been 24 reports of serious adverse events, including hospitalisation and DKA. No serious adverse events have been reported in Australia, and no deaths have been reported. This issue does not affect continuous glucose monitoring (CGM) systems or CGM readings. Insulet has identified the cause and implemented corrective actions. Pods not included in the affected lots remain safe to use, and supply is expected to continue without disruption. Insulet is contacting affected customers directly with instructions on how to check lot numbers, stop using impacted Pods, and arrange free replacements. If your Pods are affected, stop using them immediately and change to a Pod from an unaffected lot. If you need support, contact Insulet Product Support on 1800 954 074 (24/7), or speak with your healthcare professional for advice on alternative insulin delivery if needed. Further information has been provided to the Therapeutic Goods Administration (TGA).
