The UK Health Authorities have released an updated list of Field Safety Notices (FSNs) covering the…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
Critical Update: Safety Correction Issued for Siemens Healthineers 3 Tesla MRI Systems
On January 11, 2026, the FDA published an urgent alert regarding a correction by Siemens Healthineers…
FDA Early Alert: Safety Risks Identified in Integra LifeSciences Convenience Kits
The U.S. Food and Drug Administration (FDA) issued an early alert regarding safety concerns with specific…
FDA Urges Immediate Recall of Draeger ErgoStar Catheter Mounts Over Safety Risks
The FDA has issued a critical announcement regarding the recall of certain Draeger ErgoStar Catheter Mounts.…
IMPRIS Imaging Issues Urgent Medical Device Correction for IMRIS Neuro III-SV Over Safety Risks
On October 13, 2025, IMPRIS Imaging Inc. initiated an urgent correction notice for its IMRIS Neuro…
FDA Issues Critical Recall of Zenith Alpha 2 Thoracic Endovascular Graft by Cook Medical
Healthcare providers and clinical teams should be aware that the FDA has classified a recall of…
Critical Recall of FDA-Regulated Products by Gold Star Distribution Due to Severe Contamination Risks
Gold Star Distribution, Inc., has issued an urgent recall of various FDA-regulated products across three states.…
Critical Software Correction Announced for Dexcom G6 and G6 Pro Devices
Dexcom Inc. recently issued an urgent correction for its Dexcom G6 Continuous Glucose Monitoring (CGM) System’s…
Critical Update: Revised Operational Instructions for GE HealthCare Carestation Anesthesia Systems
Healthcare professionals and facility management teams utilizing GE HealthCare’s Carestation 600 and 700 Series Anesthesia Systems…
FDA Identifies Critical Update Needs for Abiomed’s Automated Impella Controllers
The Food and Drug Administration (FDA) has announced a critical update for the use of Automated…