Browse Device Recalls
18 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 18 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 18 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 holds down on a manual ... | Class II | Insulet Corporation |
| 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 issue in which a com... | Class II | Insulet Corporation |
| 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 value entered when cha... | Class I | Insulet Corporation |
| Feb 28, 2023 | Omnipod 5 Automated Insulin Delivery System | An error message was received when using the Omnipod 5 App on compatible smartphones that prevent... | Class II | Insulet Corporation |
| 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 Controller charging... | Class II | Insulet Corporation |
| 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, fluid leaking from t... | Class I | Insulet Corporation |
| 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 incorrect bolus delivery an... | Class II | Insulet Corporation |
| 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 PDM can be slowed suc... | Class II | Insulet Corporation |
| 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 PDM can be slowed suc... | Class II | Insulet Corporation |
| 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 amount based on a blo... | Class II | Insulet Corporation |
| 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 command that may result i... | Class II | Insulet Corporation |
| 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 of the needle mechan... | Class I | Insulet Corporation |
| 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 of the needle mechan... | Class I | Insulet Corporation |
| 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 deploy/retract causing ... | Class I | Insulet Corporation |
| 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 deploy/retract causing ... | Class I | Insulet Corporation |
| Feb 19, 2014 | FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. S... | Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... | Class I | Abbott Diabetes Care, Inc. |
| 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 | Insulet Corporation |
| 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 | Insulet Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.