Insulet recalls
Insulet appears in 21 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Omnipod 5 Pods
FDA Device · Class I · 2026-07-08 · Insulet - Omnipod DASH Pod
FDA Device · Class I · 2026-07-08 · Insulet - Omnipod (Eros) Pod
FDA Device · Class I · 2026-07-08 · Insulet - Omnipod 5 Pods
FDA Device · Class I · 2026-04-22 · Insulet - The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field u…
FDA Device · Class II · 2025-10-22 · Insulet - Omnipod 5 Automated Insulin Delivery System, iOS Application
FDA Device · Class II · 2025-07-02 · Insulet - Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current)
FDA Device · Class I · 2024-01-10 · Insulet - Omnipod 5 Automated Insulin Delivery System
FDA Device · Class II · 2023-09-27 · Insulet - Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Chargin…
FDA Device · Class II · 2022-12-14 · Insulet - 18239: ASM Omnipod Dash PDM, insulin delivery system
FDA Device · Class I · 2022-11-23 · Insulet - Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed t…
FDA Device · Class II · 2021-03-17 · Insulet - Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for sub…
FDA Device · Class II · 2020-06-10 · Insulet - Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subc…
FDA Device · Class II · 2020-06-10 · Insulet - 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-000…
FDA Device · Class II · 2020-04-01 · Insulet - Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
FDA Device · Class II · 2019-11-13 · Insulet - OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subc…
FDA Device · Class I · 2015-12-23 · Insulet - OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for s…
FDA Device · Class I · 2015-12-23 · Insulet - OmniPod¿ Insulin Management System
FDA Device · Class I · 2015-09-16 · Insulet - OmniPod¿ Insulin Management System
FDA Device · Class I · 2015-09-16 · Insulet - OmniPod Insulin Management System Starter Kit
FDA Device · Class II · 2013-11-13 · Insulet - OmniPod Insulin Management Product Demonstration Kit
FDA Device · Class II · 2013-11-13 · Insulet