Recall Z-0132-2026 ยท QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
Insulet Corporation
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.
| Date | Oct 10, 2025 (initiated Sep 11, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | Insulet notified both healthcare professionals and users on about 09/11/2025 via URGENT: Medical Device Correction letter. Instructions included that an update to the application will be pushed to all devices and should be implemented by users. Users were also requested to confirm receipt and acknowledgement of the notification but selecting the "acknowledgement button" in the email. |
| Quantity | 174,013 units |
| Distribution | US 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 |