Tag: medical_device_correction

FDA Issues Early Alert for Baxter Volara System Circuits Due to Leakage Risk

11 Jun 2026 1:15 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert regarding Baxter's Volara System single-patient use circuits, which may leak air and medication. This issue can lead to ineffective therapy and patient desaturation.

Health Business Science & Technology Medical Science Legal Social Issues Baxter Volara System FDA Medical Device Correction Air Leakage Patient Safety Medical Devices Food Recalls Drugs
Insulet Issues Medical Device Correction for Omnipod Pods Over Insulin Under-Delivery Risk

27 May 2026 4:51 p.m. · Source: US Food and Drug Administration

Insulet Corporation announced a voluntary medical device correction for specific Omnipod Pods due to a manufacturing issue that could cause insulin under-delivery, potentially leading to high blood glucose or DKA. Approximately 7 million Pods are affected.

Health Business Politics and Government Medical Science Federal Government Economy Legal Insulet Corporation Omnipod Medical Device Correction Insulin Under-delivery Diabetic Ketoacidosis Product Recall Acton Food Recalls FDA Drugs