Insulet recalls Omnipod 5 App software versions 1.1-1.2.3 for potential insulin over-delivery if decimal point is missed during dose changes. Users should update to latest version via Google Play.
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.
Insulet is recalling software versions 1.1 to 1.2.3 for the Omnipod 5 App on Android phones. This could cause insulin to be delivered in excess if the decimal point isn't properly entered when changing doses, potentially leading to dangerous blood sugar levels.
The software fails to record a decimal point when changing insulin doses. If the user misses this error and starts the dose without noticing, they could receive too much insulin, which might cause dangerous blood sugar drops.
People using Insulet Omnipod 5 insulin pumps with the affected software versions on Android phones. Those who change insulin doses without seeing the decimal point error may be at risk.
Check if you have the Omnipod 5 App on Android phones with software versions 1.1 through 1.2.3. In the US, this is identified by the product code PT-000599. In the EU, it's on locked-down controllers with specific UDI numbers.
Download the latest Omnipod 5 App software version from Google Play Store to fix the decimal point error.
The software may not record a decimal point when changing insulin doses, which could lead to over-delivery of insulin if the user doesn't notice the error.
Check your Omnipod 5 App version on Android phones; affected versions are 1.1 through 1.2.3. In the US, this is identified by product code PT-000599.
No, but you should update to the latest software version to prevent potential insulin over-delivery.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-0591-2024 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-0591-2024 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.