Class II recallOngoing

Omnipod 5 Automated Insulin Delivery System recall — FDA event 97597

FDA · FDA event 97597 · Posted Oct 10, 2025

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

What happened

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.

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 both healthcare professionals and users on about 09/11/2025 via URGENT: Medical Device Correction letter. Instructions included that an update to the application will be pushed to all devices and should be implemented by users. Users were also requested to confirm receipt and acknowledgement of the notification but selecting the "acknowledgement button" in the email.

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 97597
Model	Description	Lot / serial range	Manufactured	Status
Z-0132-2026	Z-0132-2026	Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X	Not provided in the normalized record	Ongoing

Distribution: US Nationwide distribution.
Units affected: See official FDA record
Category: Insulin pumps

Timeline

Sep 11, 2025
Recall initiated
Date recorded by the FDA.
Oct 10, 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: 97597
Published: Oct 10, 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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Omnipod 5 Automated Insulin Delivery System recall — FDA event 98586

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Class II recallOngoing

Omnipod 5 Automated Insulin Delivery System recall — FDA event 96945

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…

FDA · FDA event 96945Posted Jun 24, 2025Omnipod 5 Automated Insulin Delivery System

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Omnipod 5 Automated Insulin Delivery System recall — FDA event 97597

FDA · FDA event 97597 · Posted Oct 10, 2025

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

What happened

Affected products and models

Products affected by FDA event 97597
Model	Description	Lot / serial range	Manufactured	Status
Z-0132-2026	Z-0132-2026	Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X	Not provided in the normalized record	Ongoing

Distribution

US Nationwide distribution.

Units affected

See official FDA record

Omnipod 5 Automated Insulin Delivery System recall — FDA event 97597

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 97597

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