Z-0591-2024Class I

Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599...

Name: Z-0591-2024 Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599...
Creator: Insulet Corporation
Published: 2023-11-30
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2023-11-30 / Open, Classified / root cause: software

FDA source

Insulet Corporation began a recall of 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... on 2023-11-30. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0591-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-11-30
Posted: 2024-01-04
Recalling firm: Insulet Corporation
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.
Product code: QFG Alternate Controller Enabled Insulin Infusion 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.
Root cause tag: software
FDA root cause: Software design
Action: An URGENT: Medical Device Correction notification letter was sent customers on 11/30/23 via email. How do you avoid giving the wrong bolus amount? 1. When changing a bolus dose to less than 1 unit, always enter a zero (0) before the decimal (e.g., enter 0.3 instead of .3) (Figure 1) 2. Always check the bolus amount shown in the Total Bolus box before tapping CONFIRM 3. Double-check the amount on the Confirm Bolus screen (Figure 2) to make sure this is the amount you want to deliver before pressing START to deliver the bolus 4. Check the amount again while the bolus is in progress on the Delivering Bolus screen (Figure 3) As stated in our User Guide, it is important to review the bolus amount before you confirm and start the bolus. The Omnipod 5 App will always deliver the amount you confirm and that is shown on the Confirm Bolus screen (Figure 2). This amount can also be checked while the bolus is in progress on the Delivering Bolus screen (Figure 3). If it s not the amount you expected, you can always CANCEL the bolus. To check how much insulin has been delivered, check the Last Bolus box on the home screen or your History Detail. When will the issue be fixed? We are working diligently to correct this issue and expect a software update as soon as possible. We will inform your patients via email and update our website when available. Once available, the update will be pushed to their device, and they will not lose settings or history because of this update. We understand this may impact your experience and are here to support you. If you have any questions regarding the information provided in this Medical Device Correction, please call 800-591-3455 to speak with a member of the Insulet Customer Care team who are available 24 hours a day, 7 days a week.
Quantity in commerce: 27000 users
Distribution: Worldwide distribution - US Nationwide and the countries of Germany and UK.
Product codes and lots: UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10385083000206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0591-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0591-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-04

Product code QFG

K231826Class IIOmnipod 5 ACE PumpInsulet Corporation / cleared 2023-10-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)