FDA Device recall Z-0591-2024
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current)
- FDA Device
- Class I
- ongoing
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class I recall of Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current) by Insulet, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0591-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-30 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Insulet |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0591-2024%22
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