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 recall is currently active, issued October 10, 2025.
- Recall Initiated
- September 11, 2025
- Posted
- October 10, 2025
- Recall Number
- Z-0132-2026
- Quantity
- 174,013 units
- Firm Location
- Nagog Park Acton, MA
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution.
Lot / Code Info
Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
Root Cause
Software design
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.