Z-0154-2023Class I

18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL...

Name: Z-0154-2023 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL...
Creator: Insulet Corporation
Published: 2022-10-17
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2022-10-17 / Terminated / root cause: design

FDA source

Insulet Corporation began a recall of 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... on 2022-10-17. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0154-2023
Classification: Class I
Status: Terminated
Initiated: 2022-10-17
Posted: 2022-11-15
Terminated: 2024-09-17
Recalling firm: Insulet Corporation
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.
Product code: LZG Pump, Infusion, Insulin
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.
Root cause tag: design
FDA root cause: Device Design
Action: On October 17, 2022, the firm notified customers via Urgent Medical Device Correction letters sent via email. The firm followed up with physical mailers. Customers will receive updated Omnipod DASH PDMs in the coming months. Customers do not need to call to receive an updated device, one will automatically be shipped to you when available. Customers were provided with additional precautions to follow until they receive replacement units. If you have any questions regarding the information provided in this Medical Device Correction, please visit our website at www.omnipod.com/insulet-alerts or call 1-800-641-2049 to speak with a dedicated staff member of the Insulet Customer Care team who will be available 24 hours a day, 7 days a week.
Quantity in commerce: 248,288 US; 167,802 OUS
Distribution: Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.
Product codes and lots: Part Number/UDI-DI 18239 : 10385082000009 PT 000030: 10385082000122 PT 000010: 10385082000139 PT 000011: 10385082000146 All Serial Numbers and Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0154-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0154-2023	Class I	Terminated	Voluntary: Firm initiated	2022-11-23	2022-11-15

Product code LZG

K211575Class IIOmnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation / cleared 2021-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)