Insulet Corporation is recalling all software versions of the Omnipod 5 iOS App used with the Omnipod 5 Automated Insulin Delivery System, affecting approximately 122,823 downloads. The recall is due to a software design issue where the app fails to recognize a comma as a decimal separator if the user manually changes their phone's region or format settings. This error can lead the system to deliver significantly more insulin than intended. While no injuries have been reported, users should be aware that manual entries like 0.1 units could be misinterpreted as 1 unit by the app. Consumers are advised to contact their healthcare provider or the manufacturer for further guidance.
The software defect can cause the app to ignore decimal points during manual entry, leading to insulin over-delivery. This poses a high risk of severe hypoglycemia (dangerously low blood sugar), which can be life-threatening if not treated immediately.
You have 2 options:
All software versions 1.X.X; available via the Apple App Store; US market only.
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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