Omnipod 5 App — Class I medical device recall Z-0591-2024
Ongoing recall by Insulet Corporation, reported 2024-01-10, distributed nationwide. The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus
| Recall number | Z-0591-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Acton, MA, United States |
| Recall initiated | 2023-11-30 |
| Classified | 2024-01-04 |
| Reported by FDA | 2024-01-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, GB |
| Quantity | 27,000 users |
| UPC / GTIN / UDI-DI | 01038508112030, 10385083000190, 10385083000206 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0591-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.