Omnipod 5 Pods
Insulet is recalling Omnipod 5 Pods due to a cannula defect that can cause insulin under-delivery and severe health risks.
Check your Pod lot number against the list provided by Insulet. If you have an affected Pod, stop using it immediately and contact Insulet for a replacement. Monitor your blood glucose levels closely and be prepared to use an alternative method of insulin delivery if you suspect your device is not functioning correctly.
Why it was recalled
Insulet is recalling specific lots of Omnipod 5 Pods distributed nationwide due to a manufacturing defect that can cause an internal soft cannula tear. This tear may lead to insulin leaking into the device, resulting in insulin under-delivery or complete cessation of delivery, which poses a risk of severe hyperglycemia or diabetic ketoacidosis. The affected devices may not always trigger an alarm or alert the user to the failure.
Is mine affected?
This recall covers the product below. If you have it, yours is affected.
Omnipod Alternate controller enabled insulin infusion pump
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Insulet Corporation
Editorial summary by Recall Canary · last updated 2026-06-12 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification