Recall Z-2604-2026 · LZG Pump, Infusion, Insulin
Insulet Corporation
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).
| Date | Jun 30, 2026 (initiated May 20, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process design |
| Action | Insulet initially issued a press release on 05/26/2026 along with an "Urgent: Medical Device Correction" on the same day. Consignees were notified of the issue and hazard and instructed to not used Pods from affected lots and to check the lot number on the Pod tray lid, box or Pod itself to determine if affected Pods are on hand. If impacted Pods are on hand, consignees were instructed to discontinue use of any impacted Pod immediately, immediately change the Pod if currently using an affected lot, and acknowledge the email confirming receipt. Confirming receipt of the email is needed even if |
| Quantity | 1,790,784 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwait, Leichtenstein, Netherlands, Norway, Saudi Arabia, Sweden and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System Insulet Corporation, Aug 13, 2021 |