Insulet Corporation: Medical Device Recall in 2024 - (Recall #: Z-0591-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: November 30, 2023

Date Posted: January 10, 2024

Recall Number: Z-0591-2024

Event ID: 93511

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.

Status: Ongoing

Product Quantity: 27000 users

Code Information:

UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Germany and UK.

Voluntary or Mandated:

Voluntary: Firm initiated