The Medicines and Healthcare products Regulatory Agency (MHRA) has released its September 2025 safety update for…
Category: Regulatory Affairs
Global updates on medical device regulation and quality.
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…
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…
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…
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…
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…
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…
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…
Urgent Drug Warning: Outdated Patient Leaflet for Olmesartan Medoxomil Tablets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…
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…