Class II recallOngoing

Omnipod 5 Automated Insulin Delivery System recall — FDA event 96945

FDA · FDA event 96945 · Posted Jun 24, 2025

Published Jun 24, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone settings to a region OUS that uses a decimal separator instead of a period decimal separator or chooses that format as a preference. Use of the affected software may result in over delivery of insulin by increasing the amount of insulin when a decimal separator is not recognized (e.g., 0.1 unit recognized as 1 unit) and thus may result in hypoglycemia, potentially severe.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Insulet notified health care professionals and users on 05/23/2025 via emailed letter. Consignees were instructed to make sure your phone s keyboard and region settings match the approved country for use currently, the U.S. only and this issue does not affect the Insulet-provided Omnipod 5 Controllers or the Omnipod 5 App on compatible Android phones. A software update will be pushed to all devices in the coming weeks, and each consignee will be notified via email and in-app notification on the device when it is ready to install. The fix will allow commas to be recognized as decimal points when using the Omnipod 5 App for iPhone. The email notification to users included a section to formally acknowledge the notification.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This record references Omnipod 5 Automated Insulin Delivery System by Insulet Corporation.

Products affected by FDA event 96945
Model	Description	Lot / serial range	Manufactured	Status
Z-2016-2025 · all	Z-2016-2025	Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X	Not provided in the normalized record	Ongoing

Distribution: US market only- Although there are 122823 downloads of the application, our data shows there are only ~80k active users.
Units affected: See official FDA record
Category: Insulin pumps

Timeline

May 23, 2025
Recall initiated
Date recorded by the FDA.
Jun 24, 2025
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 96945
Published: Jun 24, 2025
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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Class II recallOngoing

Omnipod 5 Automated Insulin Delivery System recall — FDA event 97597

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Omnipod 5 Automated Insulin Delivery System recall — FDA event 96945

FDA · FDA event 96945 · Posted Jun 24, 2025

Published Jun 24, 2025Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Affected products and models

Products affected by FDA event 96945
Model	Description	Lot / serial range	Manufactured	Status
Z-2016-2025 · all	Z-2016-2025	Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X	Not provided in the normalized record	Ongoing

Distribution

US market only- Although there are 122823 downloads of the application, our data shows there are only ~80k active users.

Units affected

See official FDA record

Omnipod 5 Automated Insulin Delivery System recall — FDA event 96945

Follow Omnipod 5 Automated Insulin Delivery System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Omnipod 5 Automated Insulin Delivery System recall — FDA event 96945

Follow Omnipod 5 Automated Insulin Delivery System

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline