# FDA recall Z-0132-2026

> **Insulet Corporation** · Class II · device recall initiated 2025-09-11.

## Product

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0132-2026
- **Recalling firm:** Insulet Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-11
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Acton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0132-2026

## Citation

> AI Analytics. FDA recall Z-0132-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0132-2026. Source: US FDA. Licensed CC0.

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