Insulet Corporation
FDA Regulatory Profile
Insulet Corporation appears in FDA public data with 21 recalls — including 10 Class I (most serious) —, 24 510(k) clearances, 10 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2605-2026, Class I) was initiated on May 20, 2026. Its most recent 510(k) clearance was granted on June 29, 2026.
Summary
- Total Recalls
- 21 (10 Class I)
- 510(k) Clearances
- 24
- Inspections
- 10
- Compliance Actions
- 1
Recent Recalls
| 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-2603-2026 | Class I | Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-622 | May 20, 2026 |
| Z-2604-2026 | Class I | Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-5 | May 20, 2026 |
| Z-1797-2026 | Class I | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 | March 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 ent | September 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: PT- | 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: ASM, Omnipod 5, PD | November 14, 2022 |
| Z-0154-2023 | Class I | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, m | October 17, 2022 |
| Z-1203-2021 | Class II | Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 X | February 1, 2021 |
| Z-2164-2020 | Class II | Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001 | April 2, 2020 |
| Z-2165-2020 | Class II | Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D0 | April 2, 2020 |
| Z-1553-2020 | Class II | Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 | February 13, 2020 |
| Z-0347-2020 | Class II | Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 | December 18, 2018 |
| Z-0393-2016 | Class I | OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ | November 2, 2015 |
| Z-0394-2016 | Class I | OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ I | November 2, 2015 |
| Z-2485-2015 | Class I | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 | July 13, 2015 |
| Z-2484-2015 | Class I | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP | July 13, 2015 |
| Z-0166-2014 | Class II | OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Produc | September 27, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261461 | Omnipod 6 algorithm | June 29, 2026 |
| K251779 | Omnipod 5 algorithm | December 3, 2025 |
| K241777 | SmartAdjust Technology | August 26, 2024 |
| K232741 | SmartAdjust(TM) technology | May 29, 2024 |
| K231824 | SmartBolus Calculator | October 18, 2023 |
| K231826 | Omnipod 5 ACE Pump | October 18, 2023 |
| K223372 | Omnipod GO Insulin Delivery Device | April 24, 2023 |
| K222239 | SmartBolus Calculator | August 19, 2022 |
| K220394 | SmartAdjust(TM) technology | August 19, 2022 |
| K203774 | SmartAdjust technology | January 27, 2022 |
| K203772 | Omnipod 5 SmartBolus Calculator | January 27, 2022 |
| K203768 | Omnipod 5 ACE Pump (Pod) | January 27, 2022 |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | August 13, 2021 |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | October 21, 2019 |
| K191679 | Omnipod DASH Insulin Management System with interoperable technology | September 20, 2019 |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | January 8, 2019 |
| K180045 | Omnipod DASH Insulin Management System | June 1, 2018 |
| K162296 | OmniPod Insulin Management System | April 18, 2017 |
| K160252 | OmniPod Insulin Management System | April 27, 2016 |
| K140439 | OMNIPOD INSULIN MANAGEMENT SYSTEM | November 13, 2014 |