medical Class I Updated 2024-01-10

Insulet Corporation recalls Omnipod 5 App (on compatible Android smartphones), Software

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →