Insulet Corporation
Insulet Corporation holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 21 FDA device recalls on record.
Top product codes for Insulet Corporation
FDA recalls by Insulet Corporation
10 most recent of 21- Z-2603-2026 — Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3. OMNI-I1-6729 (10-Pack), OMNI-I1-6720 (Single Pod). 4. OMNI-I1-6220. 5. OMNI-I1-6720. 6. BLE-H1-529 (10-Pack), BLE-H1-520 (Single Pod).
- Z-2604-2026 — Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack), BLE-I1-520 (Single Pod). 4. BLE-C1-529 (10-Pack), BLE-C1-520 (Single Pod).
- Z-2605-2026 — Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).
- Z-1797-2026 — Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
- Z-0132-2026 — 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 using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard.
- Z-2016-2025 — Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automated Insulin Delivery System. It is used to activate/deactivate Pods, display alerts/alarms, and send insulin delivery commands for execution to the Pod. Only available in the US.
- Z-0591-2024 — Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 App Software Package (provided through Google Play), EU: PT-001323- Omnipod 5 App Software Package (provided on locked-down Controllers (PT-001194 and PT-001193). Used to control an insulin pump.
- Z-2618-2023 — Omnipod 5 Automated Insulin Delivery System
- Z-0423-2023 — Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
- Z-0154-2023 — 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Insulet Corporation
- K261461 — Omnipod 6 algorithm
- K251779 — Omnipod 5 algorithm
- K241777 — SmartAdjust Technology
- K232741 — SmartAdjust(TM) technology
- K231824 — SmartBolus Calculator
- K231826 — Omnipod 5 ACE Pump
- K223372 — Omnipod GO Insulin Delivery Device
- K220394 — SmartAdjust(TM) technology
- K222239 — SmartBolus Calculator
- K203768 — Omnipod 5 ACE Pump (Pod)
- K203772 — Omnipod 5 SmartBolus Calculator
- K203774 — SmartAdjust technology
- K211575 — Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
- K192659 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System
- K191679 — Omnipod DASH Insulin Management System with interoperable technology
- K182630 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System
- K180045 — Omnipod DASH Insulin Management System
- K162296 — OmniPod Insulin Management System
- K160252 — OmniPod Insulin Management System
- K140439 — OMNIPOD INSULIN MANAGEMENT SYSTEM
- K131294 — OMNIPOD INSULIN MANAGEMENT SYSTEM
- K122953 — OMNIPOD INSULIN MANAGMENT SYSTEM
- K111669 — FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
- K042792 — IXL-II DIABETES MANAGEMENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.