Omnipod DASH Pod — Class I medical device recall Z-2604-2026
Ongoing recall by Insulet Corporation, reported 2026-07-08, distributed nationwide. External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of be
| Recall number | Z-2604-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Acton, MA, United States |
| Recall initiated | 2026-05-20 |
| Classified | 2026-06-30 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, DK, FI, FR, GB, GR, IL, IT, KW, NL, NO, SA, SE, TR |
| Quantity | 1,790,784 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10385082000023, 10385082000115, 20385082000020, 20385082000051, 20385082000112 |
| Lot numbers | PD1U01082621, PD1U02152521, PD1U02192521, PD1U02282525, PD1U02282526, PD1U03032521, PD1U03042521, PD1U03062521, PD1U03072521, PD1U04242522, PD1U04252521, PD1U04262521, PD1U04292521, PD1U09032421, PD1U09042421, PD1U09052421, PD1U09062421, PD1U09092421, PD1U09102421, PD1U10242421, PD1U10252421, PD1U10282421, PD1U10282522, PD1U10292421, PD1U10292521, PD1U10302521, PD1U10312421, PD1U10312521, PD1U11012421, PD1U11022421, PD1U11032521, PD1U11042421, PD1U11042521, PD1U11052421, PD1U11062521, PD1U11072421, PD1U11072521, PD1U11082421, PD1U11102521, PD1U11112421 and 12 more |
| Model numbers | BLE-C1-529, BLE-I1-529, POD-BLE-I1-525, POD-BLE-I1-529 |
Product
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod).
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2604-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.