Insulet recalls Omnipod Eros Pod models with soft cannula damage causing insulin leaks. Users may face high blood sugar, DKA, or death if not corrected.
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 Omnipod Eros Pod models that have a soft cannula defect causing insulin leaks. This can lead to high blood glucose levels, diabetic ketoacidosis, or even death if not addressed.
During manufacturing, the soft cannula can damage, causing insulin to leak around the Pod instead of being delivered to the user. This leads to under-delivery of insulin, which can cause high blood glucose levels. In severe cases, prolonged high blood sugar can result in diabetic ketoacidosis, hyperosmolar hyperglycemic syndrome, or death.
People using Omnipod Eros Pod models with the listed serial numbers and lot numbers are affected. Those with diabetes who rely on insulin delivery through these devices are at highest risk.
Check for model numbers: POD-ZXP425 (10-pack), POD-ZXP420 (single pod), ZXR425 (10-pack), ZXR420 (single pod), or ZXP425 (10-pack). Also check lot numbers like L72514, L72516, or L72521.
Immediately stop using the affected Omnipod Eros Pod models to prevent insulin leaks and potential health risks.
The affected models are POD-ZXP425 (10-pack), POD-ZXP420 (single pod), ZXR425 (10-pack), ZXR420 (single pod), and ZXP425 (10-pack).
Stop using the affected Omnipod Eros Pod models immediately to prevent insulin leaks and potential health risks.
No, the affected models have a soft cannula defect that causes insulin leaks, so they should not be used.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-2605-2026 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-2605-2026 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.
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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.
