# FDA recall Z-1203-2021

> **Insulet Corporation** · Class II · device recall initiated 2021-02-01.

## Product

Omnipod DASH Insulin Management System User Guide (OUS  Only)  Product Catalog Number:   PT 000002 XXX XXX XX  PT 000318  PT 000319    Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

## Reason for recall

Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia.  Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the period as a decimal separator when entering a bolus value, this decimal separator would not be recognized by the device and any numbers entered after the period could result in a larger value than intended

## Distribution

Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

## Key facts

- **Recall number:** Z-1203-2021
- **Recalling firm:** Insulet Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-01
- **Report date:** 2021-03-17
- **Termination date:** 2023-02-08

- **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-1203-2021

## Citation

> AI Analytics. FDA recall Z-1203-2021. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-1203-2021. Source: US FDA. Licensed CC0.

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