Insulet Corporation

Complete recall history across all FDA and CPSC categories — 17 total recalls

Insulet Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (17)

FDA medical device enforcement actions by Insulet Corporation

Date Product Reason Class
Sep 11, 2025 The failure occurs if a user on the Omnipod 5 iOS application selects and hol... The failure occurs if a user on the Omnipod 5 iOS application selects and hol... Class II
May 23, 2025 Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: P... Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design ... Class II
Nov 30, 2023 Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.... The bolus calculator is not recording the decimal point if it is the first va... Class I
Feb 28, 2023 Omnipod 5 Automated Insulin Delivery System An error message was received when using the Omnipod 5 App on compatible smar... Class II
Nov 14, 2022 Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000... The firm has become aware of an issue with the Omnipod 5 Controller where the... Class II
Oct 17, 2022 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly,... The firm has become aware of PDM battery issues, including battery swelling, ... Class I
Feb 1, 2021 Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalo... Certain foreign user guides include a misprint which could lead to an incorre... Class II
Apr 2, 2020 Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Numbe... After the device has been in use for about 2 months, data processing in the P... Class II
Apr 2, 2020 Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number ... After the device has been in use for about 2 months, data processing in the P... Class II
Feb 13, 2020 Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D... In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus a... Class II
Dec 18, 2018 Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: ... There is a potential for a communication interruption following a bolus comma... Class II
Nov 2, 2015 OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Produc... Pod's needle mechanism fails to deploy or there is a delay in the deployment ... Class I
Nov 2, 2015 OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product ... Pod's needle mechanism fails to deploy or there is a delay in the deployment ... Class I
Jul 13, 2015 OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Cat... OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to dep... Class I
Jul 13, 2015 OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Ca... OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to dep... Class I
Sep 27, 2013 OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-US... Alcohol Prep Pads contained within the kit are not properly labeled. Class II
Sep 27, 2013 OmniPod Insulin Management Product Demonstration Kit; Model Reference Number:... Alcohol Prep Pads contained within the kit are not properly labeled. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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