Insulet recalls Omnipod DASH Pod models with soft cannula damage causing insulin leaks. Users may face high blood sugar, DKA, or death if not addressed. Check model numbers and lot dates for affected units.
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 DASH Pod insulin pumps that may leak insulin due to manufacturing defects. This can cause high blood glucose levels, diabetic ketoacidosis, or even death if not corrected.
The pumps have a soft cannula that can leak insulin during manufacturing, causing under-delivery of insulin. This leads to high blood glucose levels, which can cause diabetic ketoacidosis, hyperosmolar syndrome, or death if untreated.
People with diabetes using Omnipod DASH Pod insulin pumps with the listed model numbers and lot dates are affected. Those who have the specific model numbers and lot numbers from the recall list are at highest risk.
Check for model numbers: POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod), or similar variants with the listed lot numbers and UDI-DI codes.
Immediately stop using the affected Omnipod DASH Pod units as they may leak insulin and cause high blood glucose levels.
POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod), POD-BLE-I1-529 (10-Pack), BLE-I1-529 (10-Pack), and BLE-C1-529 (10-Pack) with specific lot numbers.
Insulin leaks can cause under-delivery, leading to high blood glucose levels, diabetic ketoacidosis, hyperosmolar syndrome, or death if not addressed.
Check the model number and lot numbers listed in the recall notice, which include specific UDI-DI codes and production dates.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-2604-2026 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-2604-2026 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.
