# FDA recall Z-1553-2020

> **Insulet Corporation** · Class II · device recall initiated 2020-02-13.

## Product

Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239   M/D: PDM-USA1-D001-MG-USA1    EU: PT-000010 - M/D: INT1-D001-MG         PT-000011   M/D: INT1-D001-MM    UDI 10385082000009    The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).

## Reason for recall

In certain scenarios, the Omnipod DASH PDM  may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia.

## Distribution

US Nationwide distribution. Foreign distribution to Italy, Netherlands, and United Kingdom.

## Key facts

- **Recall number:** Z-1553-2020
- **Recalling firm:** Insulet Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-13
- **Report date:** 2020-04-01
- **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-1553-2020

## Citation

> AI Analytics. FDA recall Z-1553-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1553-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*