Z-0132-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 174,013 units
Product Description
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 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 Pattern
US Nationwide distribution.
Code Information
Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X