# FDA recall Z-0423-2023

> **Insulet Corporation** · Class II · device recall initiated 2022-11-14.

## Product

Omnipod 5 Automated Insulin Delivery System  Product catalog numbers:  PT-000409: ASM, Omnipod 5, PDM, Programmed  PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US  PT-000429: Cable, Charging, Omnipod 5, Horizon PDM

## Reason for recall

The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan.

## Distribution

Domestic distribution nationwide.

## Key facts

- **Recall number:** Z-0423-2023
- **Recalling firm:** Insulet Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-14
- **Report date:** 2022-12-14

- **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-0423-2023

## Citation

> AI Analytics. FDA recall Z-0423-2023. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0423-2023. Source: US FDA. Licensed CC0.

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