Tag: early_alert

FDA Early Alert Issued After Cardinal Health Updates Instructions for Presource Packs With BD Alaris Infusion Sets

20 Oct 2026 2:41 p.m.

BD testing found previously claimed infusion performance was overestimated, with deviations most common at rates under 1 mL/h and bolus volumes of 5 mL or less.

Health Business Law Enforcement Medical Science Legal Federal Government Product Recall FDA Cardinal Health BD Alaris Pump Infusion Sets Presource Packs Medical Devices Early Alert Food Recalls Drugs BD Alaris Pump Infusion Set US Food and Drug Administration Medical Device Recalls and Early Alerts Program Infusion pumps
Boston Scientific Recalls Angiographic Catheters Over Tip Detachment Risk

28 Aug 2026 1:58 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert for Boston Scientific's Imager II Angiographic Catheters, which are being recalled due to a manufacturing defect risking tip detachment. Two serious injuries have been reported, prompting the company to discontinue the product.

Health Business Politics and Government Medical Science Federal Government Legal Boston Scientific Imager II Angiographic Catheters FDA Medical Device Recall Tip Detachment Embolism Early Alert Food Recalls Drugs
FDA Issues Early Alert for GE HealthCare Software Issue

21 Aug 2026 4:07 p.m. · Source: US Food and Drug Administration

The FDA has issued an Early Alert regarding GE HealthCare's Portrait Core Services software. An update issue may cause patient discharge from monitoring and reset alarm settings, potentially leading to loss of monitoring or alarms. No serious injuries or deaths…

Health Science & Technology Business Medical Science Computers and Internet Federal Government FDA GE HealthCare Portrait Core Services Medical Device Software Issue Patient Monitoring Early Alert Food Recalls Drugs
FDA Issues Early Alert on Hamilton Medical Breathing Circuit Sets

8 Jun 2026 12:47 p.m. · Source: US Food and Drug Administration

FDA issues an Early Alert regarding Hamilton Medical coaxial breathing circuit sets. Certain lots may not perform as intended, leading to impaired exhalation and four reported serious injuries.

Health Business Science & Technology USA Medical Science Federal Government FDA Hamilton Medical Breathing Circuit Sets Medical Devices Early Alert Respiratory Compromise Patient Safety Food Recalls Drugs