Use cautionMedical device recall · FDA · Published November 30, 2023
Insulet Omnipod 5 App Software Versions 1.1-1.2.3 May Cause Insulin Over-Delivery
Insulet recalls Omnipod 5 App software versions 1.1-1.2.3 for potential insulin over-delivery if decimal point is missed during dose changes. Users should update to latest version via Google Play.
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.
Take action
Contact the company
📍Recalling firmInsulet Corporation50 & 100 Nagog Park · Acton, MA 01720-3440
✎ GovInfoNow plain-language explainer
Insulet is recalling software versions 1.1 to 1.2.3 for the Omnipod 5 App on Android phones. This could cause insulin to be delivered in excess if the decimal point isn't properly entered when changing doses, potentially leading to dangerous blood sugar levels. Read more at govinfonow.com/recall/56714-insulet-omnipod-5-app-software-versions-1-1-1-2.
“Insulet Omnipod 5 App Software Versions 1.1-1.2.3 May Cause Insulin Over-Delivery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56714-insulet-omnipod-5-app-software-versions-1-1-1-2. Based on FDA recall #Z-0591-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0591-2024%22&limit=1).
The FDA announced on November 30, 2023, that Insulet Corporation is recalling the Omnipod 5 App for Android smartphones, software versions 1.1 through 1.2.3, due to a bolus calculator error. The hazard involves potential over-delivery of insulin if users do not recognize the error on the screen before starting a dose.
How to tell if you have it
Brand: Insulet
Product: Omnipod 5 App (on compatible Android smartphones)
Software Versions: 1.1 - 1.2.3
US Product Code: PT-000599
EU Product Code: PT-001323
Omnipod 5 App Software UDI: 1038508112030
The hazard
The bolus calculator fails to record 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.
Context
GovInfoNow's records show Insulet Corporation has 11 other recalls on record since December 18, 2018. Other recent recalls of similar products include Insulet Omnipod Eros Pod Recall (May 20, 2026), Insulet Omnipod 5 Pods Recall (March 12, 2026), and Insulet Omnipod 5 App: Insulin Entry Errors Risk Hypoglycemia (September 11, 2025). Other recent recalls of similar products include Medtronic InPen App (November 13, 2025), Medtronic MiniMed 780G Insulin Pump Recall (May 27, 2026), and Medtronic MiniMed 780G Insulin Pump Software Version 6.60 Recall (November 2, 2025).
How to tell if you have this one
Check if you have the Omnipod 5 App on Android phones with software versions 1.1 through 1.2.3. In the US, this is identified by the product code PT-000599. In the EU, it's on locked-down controllers with specific UDI numbers.
Brand
Insulet
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Download the latest Omnipod 5 App software version from Google Play Store to fix the decimal point error.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Germany and UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0591-2024 (November 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0591-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.