FDA Device recall Z-0154-2023
18239: ASM Omnipod Dash PDM, insulin delivery system
- FDA Device
- Class I
- terminated
- Published 2022-11-23
On 2022-11-23 the FDA classified a Class I recall of 18239: ASM Omnipod Dash PDM, insulin delivery system by Insulet, citing the firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0154-2023 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-10-17 |
| Published | 2022-11-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Insulet |
| Distribution | US |
Product
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.
Reason
The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.
Identifiers
| code_info | Part Number/UDI-DI 18239 : 10385082000009 PT 000030: 10385082000122 PT 000010: 10385082000139 PT 000011: 10385082000146 All Serial Numbers and Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0154-2023%22
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