The Recall Desk

Manufacturer

Insulet Corporation

21 recalls in our database name Insulet Corporation as the manufacturing or recalling firm.

What the numbers show

Total
21
Critical
1
Severe
11
Most recent
2026-07-08

Of the 21 recalls from Insulet Corporation we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 11 (52%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–21 of 21

  • CriticalFDA (Devices)·Z-2604-2026·2026-07-08

    Omnipod DASH Pod insulin pump affected by external cannula damage

    Insulet Corporation is recalling Omnipod DASH Pods worldwide due to external soft cannula damage during manufacturing that can cause insulin to leak around the pod instead of being delivered. This may lead to high blood glucose levels and, in severe cases, diabetic ketoacidosis or death.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2603-2026·2026-07-08

    Omnipod 5 Insulin Infusion Pods Recalled for External Cannula Damage

    Insulet Corporation is recalling approximately 4.9 million Omnipod 5 insulin pods due to external soft cannula damage during manufacturing that can cause insulin leakage and under-delivery, potentially leading to high blood glucose and serious diabetic complications.

    Product
    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).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2605-2026·2026-07-08

    Omnipod Eros Pod Insulin Delivery Failure Risk

    Insulet Corporation is recalling Omnipod (Eros) Pod units due to external soft cannula damage during manufacturing that can cause insulin leakage instead of delivery to the user. High blood glucose levels and serious complications including diabetic ketoacidosis (DKA) or death may result from under-delivery of insulin.

    Product
    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).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1797-2026·2026-04-22

    Omnipod 5 insulin pods from 49 lots have torn internal cannulas

    Omnipod 5 Pods from 49 lots have an internal soft cannula tear that lets insulin leak inside the Pod instead of being delivered. 1,240,115 units are affected.

    Product
    Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0132-2026·2025-10-22

    Omnipod 5 app recalled because magnifying a field duplicates typed digits

    Insulet is recalling 174,013 units of the Omnipod 5 iOS app because using the iPhone magnifier on a manual entry field while typing can duplicate a digit.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2016-2025·2025-07-02

    Omnipod 5 iOS App software design issue causes insulin overdose risk

    Insulet Corporation is recalling the Omnipod 5 iOS App due to a software issue where decimal separators are not recognized in manual insulin entry, potentially causing insulin overdose and severe hypoglycemia.

    Product
    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 t
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0591-2024·2024-01-10

    Omnipod 5 insulin pump app bolus calculator decimal point error

    The Omnipod 5 app bolus calculator may fail to record a decimal point if entered first when adjusting a dose, potentially causing insulin over-delivery. Users should verify dose values on both the calculator and confirmation screens before administering insulin.

    Product
    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).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2618-2023·2023-09-27

    Omnipod 5 App Software Error Prevented Control on Android Phones

    Omnipod 5 app users on certain Android phones encountered an error that prevented remote control of the insulin delivery system. The issue delayed therapy access but did not interrupt automatic insulin delivery, and was resolved by Insulet restoring cloud security settings.

    Product
    Omnipod 5 Automated Insulin Delivery System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0423-2023·2022-12-14

    Omnipod 5 Controller charging port melting poses minor burn risk

    Insulet is recalling Omnipod 5 Controllers where the charging port and cable may melt or deform from excessive heat, potentially causing minor burns if touched and preventing the device from charging.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0154-2023·2022-11-23

    Omnipod Dash PDM Insulin Pump Remote Recalled for Battery Fire Hazard

    Insulet Corporation is recalling the Omnipod Dash PDM remote controller for insulin pumps due to battery defects causing overheating, swelling, and fire hazard. A fire incident has been reported.

    Product
    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 (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1203-2021·2021-03-17

    Insulet Recalls Omnipod DASH User Guides Due to Decimal Error

    Insulet Corporation is recalling 21,723 Omnipod DASH User Guides distributed outside the US due to a misprint regarding decimal separators that could lead to incorrect bolus delivery.

    Product
    Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2165-2020·2020-06-10

    Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error

    Insulet Corporation is recalling 1,773 Omnipod DASH Insulin Management Systems (mmol/L configuration) because the Bolus Calculator may fail to accurately subtract insulin on board after two months of use.

    Product
    Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2164-2020·2020-06-10

    Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error

    Insulet is recalling 400 Omnipod DASH insulin systems because the Bolus Calculator may fail to subtract insulin on board correctly after two months of use.

    Product
    Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1553-2020·2020-04-01

    Insulet Omnipod DASH PDM Recalled for Inaccurate Bolus Suggestions

    Insulet is recalling Omnipod DASH Personal Diabetes Manager devices because they may suggest inaccurate bolus amounts, potentially leading to hypoglycemia or hyperglycemia.

    Product
    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-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0347-2020·2019-11-13

    Insulet Recalls Omnipod DASH Insulin Systems Due to Communication Interruption

    Insulet Corporation is recalling 264 units of the Omnipod DASH Insulin Management System because a communication interruption may cause inaccurate insulin data to be displayed.

    Product
    Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0394-2016·2015-12-23

    Insulet Recalls OmniPod Insulin Management System Due to Needle Deployment Failure

    Insulet Corporation is recalling 5,179 boxes of OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.

    Product
    OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0393-2016·2015-12-23

    Insulet Recalls OmniPod Insulin Systems Due to Needle Deployment Failure

    Insulet Corporation is recalling OmniPod Insulin Management Systems because the needle mechanism may fail to deploy or deploy with a delay.

    Product
    OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2484-2015·2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Cannula Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because the cannula may fail to deploy or retract, potentially interrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2485-2015·2015-09-16

    Insulet Recalls OmniPod Insulin Devices Due to Deployment Failures

    Insulet Corporation is recalling specific OmniPod insulin devices because they may fail to deploy or retract the cannula, potentially disrupting insulin delivery.

    Product
    OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2014·2013-11-13

    Insulet Recalls OmniPod Demonstration Kits Due to Mislabeling

    Insulet Corporation is recalling 5,050 OmniPod Insulin Management Product Demonstration Kits because the included alcohol prep pads are not properly labeled.

    Product
    OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0165-2014·2013-11-13

    Insulet Recalls OmniPod Insulin Starter Kits Due to Mislabeling

    Insulet Corporation is recalling 1,719 OmniPod Insulin Management System Starter Kits because the included alcohol prep pads are not properly labeled.

    Product
    OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diab
    Category
    Medical Device
    Distribution
    Distributed nationwide