MHRA safety roundup: July 2025

Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents.

Content

This month's Safety Roundup includes: 

• Drug Safety Update on Abrysvo (Pfizer RSV vaccine) and Arexvy (GSK RSV vaccine): be alert to a small risk of Guillain-Barré syndrome following vaccination in older adults 
• Device Safety Information on Aurum pre-filled syringes - phased introduction of new 10ml CONNECT syringe barrel: Importance of selecting compatible needle-free connectors to minimise the risk of syringe blockage
• Device Safety Information on Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus
• Device Safety Information on Updated guidance on the management of the recalled Endologix Nellix EndoVascular Aneurysm Sealing System 
• Letters, medicines recalls and device notifications sent to healthcare professionals in June and July 2025 
• News on:
• Contamination of non-sterile alcohol-free skin cleansing wipes - actions for healthcare professionals
• Passy Muir speaking valve (PMV) - reminder of safe management after incident reports
• Yellow Card Biobank recruiting patients taking GLP-1’s and experiencing acute pancreatitis
• Publication of fluoroquinolone antibiotics Public Assessment Report (PAR)
• Launch of MHRA medical device survey – Have your say