The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify
FDA device recall Z-0132-2026 · posted 2025-10-10 · Open, Classified
Recall details
- Recalling firm
- Insulet Corporation
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- QRX
- Quantity affected
- 174,013 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-09-11
- Date posted
- 2025-10-10
- Location
- Acton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Omnipod 5 ACE Pump (K231826) | Insulet Corporation | 2023-10-18 |