Omnipod DASH Insulin Management System — Class II medical device recall Z-0347-2020
Terminated recall by Insulet Corporation, reported 2019-11-13, distributed nationwide. There is a potential for a communication interruption following a bolus command that may result in inaccurate
| Recall number | Z-0347-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Billerica, MA, United States |
| Recall initiated | 2018-12-18 |
| Classified | 2019-11-07 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2020-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 264 |
| Lot numbers | L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136 |
| Model numbers | 18239, D001MG, USA1 |
Product
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Reason for recall
There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.
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-0347-2020. 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.