Insulet Corporation recalls The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on…

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0132-2026
• 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.