Insulet Corporation: Recalls
21 recall records from Sep 27, 2013 to May 20, 2026, newest first. Showing 1 to 21.
What this list covers: FDA records filed under the name "Insulet Corporation" and its spelling variant "Insulet".
Back to the Insulet Corporation profile
| Number | Class | Product | Date |
|---|
| Z-2605-2026 | Class I | Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420… | May 20, 2026 |
| Z-2604-2026 | Class I | Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack)… | May 20, 2026 |
| Z-2603-2026 | Class I | Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2… | May 20, 2026 |
| Z-1797-2026 | Class I | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 | Mar 12, 2026 |
| Z-0132-2026 | Class II | The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual… | Sep 11, 2025 |
| Z-2016-2025 | Class II | Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP… | May 23, 2025 |
| Z-0591-2024 | Class I | Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US… | Nov 30, 2023 |
| Z-2618-2023 | Class II | Omnipod 5 Automated Insulin Delivery System | Feb 28, 2023 |
| Z-0423-2023 | Class II | Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5… | Nov 14, 2022 |
| Z-0154-2023 | Class I | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100… | Oct 17, 2022 |
| Z-1203-2021 | Class II | Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002… | Feb 1, 2021 |
| Z-2165-2020 | Class II | Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D… | Apr 2, 2020 |
| Z-2164-2020 | Class II | Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D… | Apr 2, 2020 |
| Z-1553-2020 | Class II | Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1… | Feb 13, 2020 |
| Z-0347-2020 | Class II | Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 | Dec 18, 2018 |
| Z-0394-2016 | Class I | OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿… | Nov 2, 2015 |
| Z-0393-2016 | Class I | OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿… | Nov 2, 2015 |
| Z-2485-2015 | Class I | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810… | Jul 13, 2015 |
| Z-2484-2015 | Class I | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s)… | Jul 13, 2015 |
| Z-0166-2014 | Class II | OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490)… | Sep 27, 2013 |
| Z-0165-2014 | Class II | OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit)… | Sep 27, 2013 |