# FDA recall Z-0591-2024

> **Insulet Corporation** · Class I · device recall initiated 2023-11-30.

## 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.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0591-2024
- **Recalling firm:** Insulet Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-30
- **Report date:** 2024-01-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Acton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0591-2024

## Citation

> AI Analytics. FDA recall Z-0591-2024. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0591-2024. Source: US FDA. Licensed CC0.

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