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FreeStyle Libre 3 Continuous Glucose Monitoring System recall — FDA event 93393

FDA · FDA event 93393

If using affected glucose monitoring app on Android 13 Operating System, extended periods of signal loss may be experienced, due to app not connected, which could impact ability to receive glucose reading/alarms, which could lead to undetected low or high…

Posted Jan 16, 2024

Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 recall — FDA event 93474

FDA · FDA event 93474

The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to…

Posted Dec 20, 2023

BD Alaris Infusion System recall — FDA event 93106

FDA · FDA event 93106

Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

Posted Nov 7, 2023

Omnipod 5 Automated Insulin Delivery System recall — FDA event 92909

FDA · FDA event 92909

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 the…

Posted Sep 20, 2023

ICU Medical Plum 360 Infusion System recall — FDA event 92630

FDA · FDA event 92630

Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.

Posted Aug 18, 2023

FreeStyle Libre 2 Continuous Glucose Monitoring System recall — FDA event 92708

FDA · FDA event 92708

If blood glucose monitoring system users attempt to start a new sensor, when the old sensor wasn't used for the full 14-day wear time, then the reader may display "Incompatible Sensor" message. If users don't have the previous sensor, or FreeStyle Libre 2…

Posted Aug 17, 2023

Abbott

2 tracked devices · 1 recall records

Abbott Diabetes Care Inc.

3 tracked devices · 4 recall records