Recall
FDAHealthSeptember 11, 2025

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.
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.

View original FDA notice →

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