Recall database

Continuous Glucose Monitor Informed Insulin Dose Calculator recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-0132-2026

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 singl…

Continuous Glucose Monitor Informed Insulin Dose Calculator
Software design

Insulet CorporationMAOct 22, 2025

Class IIOngoingZ-2016-2025

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…

Continuous Glucose Monitor Informed Insulin Dose Calculator
Software design

Insulet CorporationMAJul 2, 2025