Insulet Corporation: Medical Device Recall in 2025 - (Recall #: Z-0132-2026)
See the recall detail below. You can also see other recalls from the same firm in 2025.
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.
Class II
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.
Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
US Nationwide distribution.
Voluntary: Firm initiated
