HIGH

Insulet Recalls Omnipod 5 App Over Insulin Delivery Risks

Insulet recalled 174,013 units of the Omnipod 5 iOS application on September 11, 2025. A software error can lead to the duplication of numbers during manual entry. This increases the risk of insulin overdelivery, potentially causing hypoglycemia.

Quick Facts at a Glance

Recall Date
September 11, 2025
Hazard Level
HIGH
Brand
Insulet
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

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

Product Details

The recall involves the Omnipod 5 App Software, specifically all software versions 2.X.X. The application is distributed nationwide in the U.S.

The Hazard

A user can inadvertently duplicate a single-digit entry when using the iPhone's magnifying feature. This duplication can result in incorrect bolus calculations, leading to insulin overdelivery.

Reported Incidents

The recall is classified as Class II. There have been no incidents reported as of the recall date, but the risk of hypoglycemia is significant.

What to Do

Patients and healthcare providers should stop using the app immediately. Follow the instructions provided by Insulet Corporation via email or contact your healthcare provider.

Contact Information

For further information, contact Insulet Corporation or visit their website. Notification will be sent via email.

Key Facts

  • Recall date: September 11, 2025
  • Quantity recalled: 174,013 units
  • Hazard level: High
  • Software error may cause insulin overdelivery
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeInsulin Delivery App
Sold At
Multiple Retailers

Product Details

Brand
Insulet
Model Numbers
Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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