Pod Recall: Insulet Omnipod 5
Announced 2026-07-08 · FDA
FDA recall on the Omnipod 5 iOS app software (UDI 10385083000459) covering all 2.X.X versions. The issue occurs when magnifying a manual entry field while selecting a digit, duplicating the digit and potentially causing errors in bolus-related entries. This could lead to over-delivery of insulin and possible hypoglycemia; about 174,013 units distributed nationwide in the US.
| Brand | Insulet Corporation |
|---|---|
| Product | The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. |
| Reason | The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia. |
| Severity | moderate |
| Units affected | 4936056 |
| Distribution | US Nationwide distribution. |
| Agency | FDA |
| Recall / campaign no. | Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X |
WHAT YOU SHOULD DO
- Stop using the magnifying feature when entering numbers in the Omnipod 5 iOS app until further notice.
- Verify manually entered bolus and other values before delivery; correct any mistakes.
- Update the Omnipod 5 app to the latest version or follow recall guidance from Insulet.
- Monitor blood glucose closely and contact your healthcare provider if you notice symptoms of hypoglycemia.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.