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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96945

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 23, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Insulet Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.

Z-2016-2025
Recall number
Z-2016-2025
Initiated
May 23, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Insulet Corporation
Quantity
122,823 downloads

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software design issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Model Number: PT-000664/M009-S-AP. UDI-DI: 10385083000336. All software versions 1.X.X

Distribution pattern

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