Insulet recalls Omnipod 5 iOS app software versions 2.X.X due to potential insulin overdose from entry errors when using iPhone magnification. Affected users should contact Insulet for updates.
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.
Insulet is recalling the Omnipod 5 iOS app software versions 2.X.X because a specific way of using iPhone magnification while entering insulin doses can cause duplicate numbers, leading to over-delivery of insulin and hypoglycemia. This risk affects people who use the Omnipod 5 system with iPhone for insulin management.
When users hold down on a manual entry field in the Omnipod 5 app to magnify the iPhone screen while typing a single number, the app duplicates that digit. This can cause incorrect insulin doses to be entered, potentially leading to too much insulin being delivered and causing dangerously low blood sugar levels.
People who use the Omnipod 5 insulin delivery system with the iPhone app to enter insulin doses are most at risk. This includes individuals managing diabetes with this specific device.
Check if you own the Omnipod 5 system with the iPhone app version 2.X.X. The unique device identifier (UDI) is 10385083000459.
Verify your Omnipod 5 app version by checking the app store settings or the device's software information.
Reach out to Insulet directly for guidance on whether your version is affected and what steps to take next.
The recall states this could result in over-delivery of insulin leading to hypoglycemia, which may cause serious health issues but does not explicitly state it can cause death or serious injury in normal use.
Check if your Omnipod 5 app is version 2.X.X, as the unique device identifier (UDI) 10385083000459 is associated with this specific software version.
The recall does not specify a stop-use instruction; users are advised to check their app version and contact Insulet for guidance.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-0132-2026 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-0132-2026 from Insulet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
