June 24, 2025

Jun

FDA Recall: Use of the affected software may result in over delivery of insulin

June 24, 2025Allison PateNews

Company: Insulet Corporation Date of Enforcement Report: 6/24/2025 Class: II 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 that controls the Omnipod 5...

Jun

FDA Recall: Error may lead to an error preventing user access to the dispensing software application

June 24, 2025Allison PateNews

Company: CareFusion 303, Inc. Date of Enforcement Report: 6/24/2025 Class: II PRODUCT Product Name [REF]: Supply Server CCE Enterprise SW Site License (2-5) BD Pyxis Logistics [806] BD Pyxis MedStation 4000 Main 10885403512629 [303] BD Pyxis MedStation ES Tower 10885403512674 [352] BD Pyxis Anesthesia Station ES 10885403477836 [327] BD Pyxis MedStation ES (Main) 10885403512667 [323]...

FDA Recall: Use of the affected software may result in over delivery of insulin

FDA Recall: Error may lead to an error preventing user access to the dispensing software application

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FDA Recall: Use of the affected software may result in over delivery of insulin

FDA Recall: Error may lead to an error preventing user access to the dispensing software application

Upcoming Public Courses

Corporate Office