Insulet Corporation has issued a recall for the Omnipod 5 App affecting approximately 27,000 users worldwide. The app's bolus calculator software may fail to record a decimal point if it is the first value entered when a user is changing their insulin dose, potentially leading to a significantly higher dose than intended. This issue affects software versions 1.1 through 1.2.3 used on compatible Android smartphones and locked-down controllers.
If the decimal point is not recorded, a user intending to enter a small dose (such as .5 units) might unknowingly enter a much larger dose (5 units). This error can lead to the over-delivery of insulin, which may cause severe hypoglycemia (low blood sugar) and require medical intervention.
Software use caution and manufacturer contact
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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