Reported Oct 22, 2025 · Ongoing
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to…
Insulet Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Insulet Corporation · 50 & 100 Nagog Park · Acton, MA · 01720-3440
Is this the product you have?
- 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 codes and dates
- Omnipod 5 App Software
- UDI10385083000459. All software versions 2.X.X
- Amount recalled
- 174,013 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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