Use caution Medical device recall · FDA · Published September 11, 2025

Insulet Omnipod 5 App: Insulin Entry Errors Risk Hypoglycemia

Insulet recalls Omnipod 5 iOS app software versions 2.X.X due to potential insulin overdose from entry errors when using iPhone magnification. Affected users should contact Insulet for updates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0132-2026Medical device Insulet ›

Use caution until it’s fixed

The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.

Take action

Contact the company

Recalling firmInsulet Corporation50 & 100 Nagog Park · Acton, MA 01720-3440

✎ GovInfoNow plain-language explainer

Insulet is recalling the Omnipod 5 iOS app software versions 2.X.X because a specific way of using iPhone magnification while entering insulin doses can cause duplicate numbers, leading to over-delivery of insulin and hypoglycemia. This risk affects people who use the Omnipod 5 system with iPhone for insulin management. Read more at govinfonow.com/recall/51346-insulet-omnipod-5-app-insulin-entry-errors-risk-hypoglycemia.

Source Summary by GovInfoNow · govinfonow.com/recall/51346-insulet-omnipod-5-app-insulin-entry-errors-risk-hypoglycemia · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0132-2026

Cite this page

“Insulet Omnipod 5 App: Insulin Entry Errors Risk Hypoglycemia.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51346-insulet-omnipod-5-app-insulin-entry-errors-risk-hypoglycemia. Based on FDA recall #Z-0132-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0132-2026%22&limit=1).

The FDA announced on September 11, 2025, that Insulet Corporation is recalling Omnipod 5 iOS application software versions 2.X.X due to a hazard of insulin overdelivery. The defect causes digit duplication when users magnify the screen while entering numbers, potentially leading to hypoglycemia.

How to tell if you have it

Brand: Insulet
Product: Omnipod 5 App Software
Software versions: 2.X.X
UDI: 10385083000459

The hazard

The hazard occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field to magnify the visual field using the iPhone's magnifying feature while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate, resulting in errors in manual entry of digits such as bolus entry or I:C ratio. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.

Context

GovInfoNow's records show Insulet Corporation has had 11 other recalls since December 18, 2018. Recent similar recalls include the Insulet Omnipod Eros Pod Recall (May 20, 2026) for insulin leaking risk and the Insulet Omnipod 5 Pods Recall (March 12, 2026) for internal leak risk. Other recent recalls of similar products include the Medtronic InPen App recall (November 13, 2025), the Medtronic MiniMed 780G Insulin Pump Recall (May 27, 2026), and the Medtronic MiniMed Go App Version 1.0.0/1.1.0 recall (June 16, 2026).

How to tell if you have this one

Check if you own the Omnipod 5 system with the iPhone app version 2.X.X. The unique device identifier (UDI) is 10385083000459.

Brand
Insulet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check App Version
Verify your Omnipod 5 app version by checking the app store settings or the device's software information.
Contact Insulet
Reach out to Insulet directly for guidance on whether your version is affected and what steps to take next.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 41 days after the firm started it.

Sep 11, 2025Firm started the recall
Oct 10, 2025FDA classified it Class II
Oct 22, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Can this cause serious injury?

The recall states this could result in over-delivery of insulin leading to hypoglycemia, which may cause serious health issues but does not explicitly state it can cause death or serious injury in normal use.

Similar recalls

Latest medical device recalls

Keep exploring

More Insulet recalls

Link to this recall

<a href="https://govinfonow.com/recall/51346-insulet-omnipod-5-app-insulin-entry-errors-risk-hypoglycemia">Insulet Omnipod 5 App: Insulin Entry Errors Risk Hypoglycemia (GovInfoNow)</a>

Where this comes from

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-0132-2026 (September 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0132-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.