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 iPho
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 11, 2025
US Nationwide distribution.
What's affected?
- 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.
- Brand
- Insulet Corporation
- Lot code
- Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
Additional details
Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 174,013 units.
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