Insulet recalled 174,013 Omnipod 5 iOS app software units distributed nationwide in the United States. The recall cites a magnifying feature bug that can duplicate a single-digit entry. This could lead to bolus insulin dosing errors and hypoglycemia. Stop using the app immediately and follow recall instructions from Insulet or your healthcare provider.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Insulet Corporation or your healthcare provider for instructions. Notification method: E-Mail
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Omnipod 5 is a wireless insulin pump system controlled by a mobile app. The iOS app manages bolus delivery and dosing calculations. The recall concerns a software bug in the iOS app that can alter dose entries when magnifying digits.
The magnify-and-enter bug can duplicate a single digit, leading to incorrect bolus, ratio settings, or calculator results. This may cause over-delivery of insulin and hypoglycemia.
This recall is not described as part of a broader industry pattern.
The issue directly affects diabetes management. It creates an immediate risk for users who rely on precise insulin dosing and may require urgent medical monitoring.
Official recall information is available on Insulet’s site and the FDA recall enforcement page. Look for Z-0132-2026.
Remediation timelines vary; expect updates within weeks to months. Recipients may need software updates or alternative management guidance.
Maintain copies of recall notices, emails from Insulet, and records of any dosing events or communication with providers.
Model numbers: Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X. Where sold: United States nationwide distribution. When sold: Recall date 2025-09-11. Price: Unknown.
No injuries or incidents have been reported.
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