Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all P

FDA device recall Z-2016-2025 · posted 2025-06-24 · Open, Classified

Recall details

Recalling firm

Insulet Corporation

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

QRX

Quantity affected

122,823 downloads

Distribution

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

Date initiated

2025-05-23

Date posted

2025-06-24

Location

Acton, MA

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