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Insulet Corporation

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1- recall (Z-2603-2026)Insulet Corporation2026-06-30
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BL recall (Z-2604-2026)Insulet Corporation2026-06-30
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZX recall (Z-2605-2026)Insulet Corporation2026-06-30
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 recall (Z-1797-2026)Insulet Corporation2026-04-10
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a recall (Z-0132-2026)Insulet Corporation2025-10-10
Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009 recall (Z-2016-2025)Insulet Corporation2025-06-24
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current) recall (Z-0591-2024)Insulet Corporation2024-01-04
Omnipod 5 Automated Insulin Delivery System recall (Z-2618-2023)Insulet Corporation2023-09-20
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnip recall (Z-0423-2023)Insulet Corporation2022-12-07
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM recall (Z-0154-2023)Insulet Corporation2022-11-15
OmniPod, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The Omnni recall (Z-0393-2016)Insulet Corporation2015-12-15
OmniPod, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod recall (Z-0394-2016)Insulet Corporation2015-12-15
OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): recall (Z-2484-2015)Insulet Corporation2015-09-04
OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): recall (Z-2485-2015)Insulet Corporation2015-09-04
OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter recall (Z-0165-2014)Insulet Corporation2013-11-05
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) recall (Z-0166-2014)Insulet Corporation2013-11-05

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Every clearance here is in the API, with alerts when new ones post.