Insulet Corporation: Device Recall

Recall #Z-0132-2026 · 09/11/2025

Class II: Risk

Recall Details

Recall Number: Z-0132-2026
Classification: Class II
Product Type: Device
Recalling Firm: Insulet Corporation
Status: Ongoing
Date Initiated: 09/11/2025
Location: Acton, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 174,013 units

Reason for Recall

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.

Product Description

Distribution Pattern

US Nationwide distribution.

Other Recalls by Insulet Corporation

Class II: Risk 05/23/2025

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.

View all recalls by Insulet Corporation →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.