Omnipod 5 Pods
Insulet recalls Omnipod 5 Pods over insulin leakage risk that may cause high blood glucose, DKA, or HHS.
Stop using the affected Omnipod 5 Pods immediately. Contact Insulet Corporation for a replacement or further instructions. Monitor your blood glucose levels closely and seek medical attention if you experience symptoms of high blood glucose or DKA.
Why it was recalled
Insulet Corporation is recalling Omnipod 5 Pods due to a manufacturing defect that can cause external soft cannula damage, leading to insulin leakage around the Pod instead of proper delivery. This under-delivery may result in high blood glucose levels, potentially causing diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS).
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Omnipod 5 Pods. Includes the below Model/REF Numbers | 20385083000579, 10385083000527, 20385083000425 | Z-2603-2026 |
| Omnipod DASH Pod. Includes the below Model/REF Numbers | 20385082000051, 10385082000023, 20385082000020, 10385082000023, 20385082000020, 10385082000023, 20385082000112, 10385082000115 | Z-2604-2026 |
| Omnipod (Eros) Pod. Includes the below Model/REF Numbers | 20385081120033, 10385081120036, 20385081120033, 10385081120036 | Z-2605-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Insulet Corporation
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification