# FDA recall Z-2164-2020

> **Insulet Corporation** · Class II · device recall initiated 2020-04-02.

## Product

Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010  M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

## Reason for recall

After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.

## Distribution

The products were distributed to the following foreign countries:  Italy, Netherlands, UK.

## Key facts

- **Recall number:** Z-2164-2020
- **Recalling firm:** Insulet Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-02
- **Report date:** 2020-06-10
- **Termination date:** 2021-09-14

- **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-2164-2020

## Citation

> AI Analytics. FDA recall Z-2164-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2164-2020. Source: US FDA. Licensed CC0.

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