Z-0591-2024 Class I Ongoing
FDA device recall Z-0591-2024 was initiated by Insulet Corporation on Nov 30, 2023 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 27000 users.
Recall details
- Product Type
- Devices
- Report Date
- Jan 10, 2024
- Initiation Date
- Nov 30, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27000 users
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.
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 pattern
Worldwide distribution - US Nationwide and the countries of Germany and UK.
Code information
UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0591-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026