# FDA recall Z-0154-2023

> **Insulet Corporation** · Class I · device recall initiated 2022-10-17.

## Product

18239: ASM Omnipod Dash PDM, insulin delivery system.    PT-000010: Assembly, Dash Final PDM U100, mg/dL  PT-000011: Assembly, Dash Final PDM U100, mmol/L  PT-000030: Assembly, DASH PDM, Canada    Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod)      *The part numbers above may be incorporated  into higher level assemblies such as DASH Starter  Kits.

## Reason for recall

The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.

## Distribution

Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.

## Key facts

- **Recall number:** Z-0154-2023
- **Recalling firm:** Insulet Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-10-17
- **Report date:** 2022-11-23
- **Termination date:** 2024-09-17

- **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-0154-2023

## Citation

> AI Analytics. FDA recall Z-0154-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0154-2023. Source: US FDA. Licensed CC0.

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