Insulet Corporation: Medical Device Recall in 2022 - (Recall #: Z-0154-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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 Classification:

Class I

Date Initiated: October 17, 2022

Date Posted: November 23, 2022

Recall Number: Z-0154-2023

Event ID: 90987

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.

Status: Terminated

Product Quantity: 248,288 US; 167,802 OUS

Code Information:

Part Number/UDI-DI 18239 : 10385082000009 PT 000030: 10385082000122 PT 000010: 10385082000139 PT 000011: 10385082000146 All Serial Numbers and Lots

Distribution Pattern:

Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.

Voluntary or Mandated:

Voluntary: Firm initiated