Insulet recalls Omnipod 5 Pods with specific model numbers due to manufacturing defect causing insulin leaks, potentially leading to high blood sugar and serious health risks.
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users 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), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Insulet is recalling certain Omnipod 5 Pods that may leak insulin due to a manufacturing defect. This can cause high blood glucose levels, and in severe cases, lead to diabetic ketoacidosis or even death.
During manufacturing, the soft cannula can become damaged, causing insulin to leak around the Pod instead of being delivered to the user. This results in under-delivery of insulin, which can cause high blood glucose levels. Prolonged high blood glucose may lead to serious complications like diabetic ketoacidosis or death.
People using Omnipod 5 Pods with the listed model numbers are affected. Those with diabetes who rely on insulin delivery from these pods are at the highest risk.
Check the model numbers: POD-OMNI-I1-6720, POD-OMNI-I1-6220, OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod), and OMNI-I1-6220 (Single Pod). Also check the lot numbers listed in the recall notice.
Look for the model numbers: POD-OMNI-I1-6720, POD-OMNI-I1-6220, OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod), or OMNI-I1-6220 (Single Pod).
Reach out to Insulet directly to confirm if your specific Pod is affected and get instructions on next steps.
The affected model numbers are POD-OMNI-I1-6720, POD-OMNI-I1-6220, OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod), and OMNI-I1-6220 (Single Pod).
The Pods may leak insulin during use, causing under-delivery of insulin. This can lead to high blood glucose levels and, in severe cases, diabetic ketoacidosis or death.
The recall does not require immediate stoppage; however, users should check if their Pods are affected and contact Insulet for guidance.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-2603-2026 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-2603-2026 from Insulet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
