Recall Z-1797-2026 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Insulet Corporation
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
| Date | Apr 10, 2026 (initiated Mar 12, 2026) |
| Status | Open, Classified |
| Reason | Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a |
| Root cause | Process design |
| Action | Insulet notified consignees via press release and letters sent via email primarily and also text message on 03/12/2026. The press release instructed users to visit omnipod.com/check-pods to confirm whether their Pod lot number is affected, discontinue use of any affected pods and replace it with a Pod from an unaffected lot. Consignees were asked to contact Insulet to arrange for the return of any affected Pods on hand. Patients were directly notified and instructed to visit omnipod.com/check-pods to acknowledge receipt and check to see if their lot is affected, DO NOT use Pods from the aff |
| Quantity | 1,240,115 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K231826 | Omnipod 5 ACE Pump Insulet Corporation, Oct 18, 2023 |