Home / Recalls / Insulet Corporation / Z-0154-2023

Z-0154-2023 Class I Terminated

Recalled by Insulet Corporation — Acton, MA

Recall Details

Product Type
Devices
Report Date
November 23, 2022
Initiation Date
October 17, 2022
Termination Date
September 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
248,288 US; 167,802 OUS

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.

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.

Distribution Pattern

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

Code Information

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

Other recalls by Insulet Corporation

  • Z-0132-2026 Class II — The failure occurs if a user on the Omnipod 5 iOS application selects and holds (September 11, 2025)
  • Z-2016-2025 Class II — Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-0 (May 23, 2025)
  • Z-0591-2024 Class I — Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (November 30, 2023)
  • Z-2618-2023 Class II — Omnipod 5 Automated Insulin Delivery System (February 28, 2023)
  • Z-0423-2023 Class II — Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409 (November 14, 2022)
  • Z-1203-2021 Class II — Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog N (February 1, 2021)
  • Z-2165-2020 Class II — Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number P (April 2, 2020)
  • Z-2164-2020 Class II — Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT0 (April 2, 2020)
  • Z-1553-2020 Class II — Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: P (February 13, 2020)
  • Z-0347-2020 Class II — Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM (December 18, 2018)