Regulatory Affairs

October 2, 2025 Dr. Hatem Rabeh

Critical Safety Update: MHRA Reinforces September 2025 Guidelines for Medicines and Device Users

The Medicines and Healthcare products Regulatory Agency (MHRA) has released its September 2025 safety update for medicines and medical devices.…

FDA Warns About Safety Concerns with Boston Scientific Accolade Pacemakers: Early Replacement Recommended

The FDA has issued a safety communication regarding Boston Scientific’s Accolade family of pacemakers, highlighting the potential need for early…

Urgent Recall Alert: Packaging Seal Defect Identified in ChloraPrep 1mL Applicators

Becton Dickinson UK Ltd has issued a notification to recall certain batches of its ChloraPrep 1mL Clear Sterile Solution/Applicator due…

Philips Respironics Recall: Programming Errors in DreamStation Devices Highlight Patient Risks

Philips Respironics has announced the recall of certain DreamStation Auto CPAP and Auto BiPAP devices due to programming errors that…

Critical Update: Revised UK Guidance on Managing Endologix Nellix EVAS System Recall

The Medicines and Healthcare products Regulatory Agency (MHRA) has released significant updates regarding the management of patients who previously received…

Critical FDA Update: Defibrillation Lead Advisory from Boston Scientific

The FDA has issued a public update regarding Boston Scientific’s ENDOTAK RELIANCE Defibrillation leads, highlighting potential risks tied to expanded…

Critical Field Safety Notices Alert: Updates from 21–25 July 2025

Field safety notices issued between 21 and 25 July 2025 have highlighted significant device recalls and updates requiring close attention…

Critical Update for Dexcom Continuous Glucose Monitor Apps: Software Correction Addresses Missed Failure Alerts

Dexcom, Inc. has issued a correction for its Dexcom G7 Continuous Glucose Monitoring (CGM) Apps and Dexcom ONE+ CGM Apps…

Urgent Drug Warning: Outdated Patient Leaflet for Olmesartan Medoxomil Tablets

Jubilant Pharmaceuticals NV has reported a packaging error involving certain batches of Olmesartan medoxomil 10mg film-coated tablets. According to the…

Critical Recall Update: BD Alaris™ Pump Infusion Sets Expand Warning to Higher Risks

Medical technology manufacturer BD has announced an expanded voluntary recall of certain BD Alaris™ Pump Module model 8100 infusion sets.…

July 2025 MHRA Safety Update: Essential Guidance for Medicines and Medical Devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has released its latest safety guidance aimed at users of medicines and…

FDA Alert: Tandem Diabetes Care Updates t:slim X2 Insulin Pumps Due to Potential Speaker Wiring Fault

Tandem Diabetes Care has issued an urgent correction addressing potential risks associated with certain t:slim X2 insulin pumps. Healthcare professionals,…