18239: ASM Omnipod Dash PDM — Class I medical device recall Z-0154-2023
Terminated recall by Insulet Corporation, reported 2022-11-23, distributed nationwide. The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, a
| Recall number | Z-0154-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Acton, MA, United States |
| Recall initiated | 2022-10-17 |
| Classified | 2022-11-15 |
| Reported by FDA | 2022-11-23 |
| Terminated | 2024-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10385082000009, 10385082000122, 10385082000139, 10385082000146 |
| Lot numbers | 18239 |
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 for recall
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.
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-0154-2023. 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.