Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2016-2025
• FDA 510(k) clearance · K231826The device's official FDA premarket clearance record
• FDA device classification · QRXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1358The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Insulet CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.