PlainRecalls
FDA Devices Critical Class I Ongoing

Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.

Reported: January 10, 2024 Initiated: November 30, 2023 #Z-0591-2024

Product Description

Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.

Reason for Recall

The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.

Details

Recalling Firm
Insulet Corporation
Units Affected
27000 users
Distribution
Worldwide distribution - US Nationwide and the countries of Germany and UK.
Location
Acton, MA

Frequently Asked Questions

What product was recalled? ▼
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.. Recalled by Insulet Corporation. Units affected: 27000 users.
Why was this product recalled? ▼
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 10, 2024. Severity: Critical. Recall number: Z-0591-2024.

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