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The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual ...

FDA Recall #Z-0132-2026 — Class II — September 11, 2025

Recall #Z-0132-2026 Date: September 11, 2025 Classification: Class II Status: Ongoing

Product Description

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.

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.

Recalling Firm

Insulet Corporation — Acton, MA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

174,013 units

Distribution

US Nationwide distribution.

Code Information

Omnipod 5 App Software. UDI: 10385083000459. All software versions 2.X.X

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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