Tag: medical_device_correction

Nova Biomedical Issues Global Correction for StatStrip Glucose Hospital Meter Over Patient Mix-Up Risk

7 Oct 2026 5:09 p.m. · Source: US Food and Drug Administration

Nova Biomedical's global Medical Device Correction for the Gen 2.0 StatStrip Glucose Hospital Meter follows a software flaw that may link glucose results to the wrong patient.

Health Business Science & Technology Medical Science Law Enforcement Legal Nova Biomedical StatStrip Glucose Hospital Meter Medical Device Correction Product Recall US Food and Drug Administration Glucose Monitoring Patient Safety Food Recalls FDA Drugs
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