Insulet recalls Omnipod 5 iOS App software (model PT-000664/M009-S-AP) due to a decimal separator issue that may cause insulin overdelivery and hypoglycemia. Affected users should contact Insulet for guidance.
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.
Insulet is recalling the Omnipod 5 iOS App software because a software design flaw prevents users from entering decimal numbers correctly. This could cause insulin to be delivered in larger amounts than intended, potentially leading to severe hypoglycemia.
The app fails to recognize commas as decimal separators when users set their phone to regions that use commas instead of periods. This causes the app to misinterpret numbers like 0.1 as 1, leading to higher insulin doses. Overdelivery can cause dangerous low blood sugar levels.
People using the Omnipod 5 insulin delivery system with the affected iOS App software are at risk. Those who manually change their phone settings to use a comma as a decimal separator are most vulnerable.
Check if your Omnipod 5 system uses the iOS App software with model number PT-000664/M009-S-AP. The affected software is all versions 1.X.X available through the Apple App Store in the US.
Verify if your phone settings use a comma as the decimal separator instead of a period.
Reach out to Insulet for guidance on updating the software or alternative solutions.
The app has a software design issue that prevents users from entering decimal numbers correctly when their phone settings use a comma as the decimal separator.
Insulin may be delivered in larger amounts than intended, potentially causing severe hypoglycemia.
Check your Omnipod 5 system's iOS App software model number: PT-000664/M009-S-AP, available through the Apple App Store in the US.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-2016-2025 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-2016-2025 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.
