FDA Device recall Z-0347-2020
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
- FDA Device
- Class II
- terminated
- Published 2019-11-13
On 2019-11-13 the FDA classified a Class II recall of Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 by Insulet, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0347-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-12-18 |
| Published | 2019-11-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Insulet |
| Distribution | US |
Product
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Reason
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.
Identifiers
| code_info | Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0347-2020%22
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