--- title: "Insulet Corporation Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Insulet Corporation recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/insulet-corporation/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Insulet Corporation recall records **9** reported ongoing 11 records in this archive. Latest source date May 20, 2026. 1 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status May 20, 2026 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-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/) External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an exter... Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwai... [Official source for Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. POD-OMNI-I1-6220. 3...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2603-2026%22) May 20, 2026 FDA device enforcement ### [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...](https://isitonrecall.com/recall/fda-device-z-2604-2026-omnipod-dash-pod-includes-the-below-model-ref-numbers-1-pod-ble-i1-525-5-pack-pod-ble-i1-520-single/) External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an exter... Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwai... [Official source for Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-52...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2604-2026%22) May 20, 2026 FDA device enforcement ### [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), ZXP42...](https://isitonrecall.com/recall/fda-device-z-2605-2026-omnipod-eros-pod-includes-the-below-model-ref-numbers-1-pod-zxp425-10-pack-pod-zxp420-single-pod-2-z/) External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an exter... Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Finland, France, UK, Greece, Israel, Italy, Kuwai... [Official source for Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (S...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2605-2026%22) Mar 13, 2026 FDA company announcement ### [Omnipod: Alternate controller enabled insulin infusion pump](https://isitonrecall.com/recall/fdapress-914430f969aed6ea-omnipod-alternate-controller-enabled-insulin-infusion-pump/) Pods may have a small tear in the internal tubing that delivers insulin. This may leak inside the Pod instead of being fully infused into the body as intended. Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for Omnipod: Alternate controller enabled insulin infusion pump](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-5-pods-us) Mar 12, 2026 FDA device enforcement ### [Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7](https://isitonrecall.com/recall/fda-device-z-1797-2026-omnipod-5-pods-model-catalog-number-pt-001662-asm-5pk-pod-strl-ops-g6g7/) Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage ... Class I Reported ongoing Distribution: Nationwide distribution. [Official source for Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1797-2026%22) Sep 11, 2025 FDA device enforcement ### [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 iPh...](https://isitonrecall.com/recall/fda-device-z-0132-2026-the-failure-occurs-if-a-user-on-the-omnipod-5-ios-application-selects-and-holds-down-on-a-manual-ent/) 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. This causes... Class II Reported ongoing Distribution: US Nationwide distribution. [Official source for The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0132-2026%22) May 23, 2025 FDA device enforcement ### [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 ava...](https://isitonrecall.com/recall/fda-device-z-2016-2025-omnipod-5-automated-insulin-delivery-system-ios-application-model-number-pt-000664-m009-s-ap-softwar/) Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone se... Class II Reported ongoing Distribution: US market only- Although there are 122823 downloads of the application, our data shows there are only ~80k active users. [Official source for Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2016-2025%22) Nov 30, 2023 FDA device enforcement ### [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-...](https://isitonrecall.com/recall/fda-device-z-0591-2024-omnipod-5-app-on-compatible-android-smartphones-software-versions-1-1-1-2-3-current-us-pt-000599-omn/) The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the conf... Class I Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Germany and UK. [Official source for Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: P...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0591-2024%22) Feb 28, 2023 FDA device enforcement ### [Omnipod 5 Automated Insulin Delivery System](https://isitonrecall.com/recall/fda-device-z-2618-2023-omnipod-5-automated-insulin-delivery-system/) An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in therapy. To reduce t... Class II Reported ongoing Distribution: Distribution throughout the US [Official source for Omnipod 5 Automated Insulin Delivery System](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2618-2023%22) Nov 14, 2022 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-0423-2023-omnipod-5-automated-insulin-delivery-system-product-catalog-numbers-pt-000409-asm-omnipod-5-pdm-prog/) The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause ... Class II Reported ongoing Distribution: Domestic distribution nationwide. [Official source for Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, P...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0423-2023%22) Oct 17, 2022 FDA device enforcement ### [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 ...](https://isitonrecall.com/recall/fda-device-z-0154-2023-18239-asm-omnipod-dash-pdm-insulin-delivery-system-pt-000010-assembly-dash-final-pdm-u100-mg-dl-pt-0/) The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM. Class I Reported terminated Distribution: Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East. [Official source for 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, m...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0154-2023%22) ## Reasons in these listed records - External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin... - Pods may have a small tear in the internal tubing that delivers insulin. This may leak inside the Pod instead of being fully infused into the body as intended. - Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed por... - 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. This causes the single digit nu... These examples come from this result page and are not a ranking of every recall reason. ## Checking Insulet Corporation ### Is there a recall on insulet corporation right now? This archive contains 11 records, including 9 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Insulet Corporation](https://isitonrecall.com/check/?q=Insulet%20Corporation) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)