Omnipod DASH Insulin Management System — Class II medical device recall Z-2165-2020
Terminated recall by Insulet Corporation, reported 2020-06-10. After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bo
| Recall number | Z-2165-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Acton, MA, United States |
| Recall initiated | 2020-04-02 |
| Classified | 2020-05-29 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2021-09-14 |
| Countries outside the US | GB, IT, NL |
| Quantity | 1,773 |
| UPC / GTIN / UDI-DI | 10385082000146 |
| Lot numbers | L000200, L000201, L000203, L000209, L000210 |
| Model numbers | INT1D001MM, PT000011 |
Product
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2165-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.