Insulet Corporation
10 recalls on record · Latest: Jan 10, 2024
FDA Devices Critical Jan 10, 2024
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided …
FDA Devices Moderate Sep 27, 2023
Omnipod 5 Automated Insulin Delivery System
FDA Devices Critical Nov 23, 2022
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, m…
FDA Devices Moderate Mar 17, 2021
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to…
FDA Devices Moderate Apr 1, 2020
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-…
FDA Devices Moderate Nov 13, 2019
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
FDA Devices Critical Dec 23, 2015
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutan…
FDA Devices Critical Dec 23, 2015
OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcut…
FDA Devices Critical Sep 16, 2015
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of ins…
FDA Devices Critical Sep 16, 2015