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Urgent Field Safety Notice for Azurion by Philips Nordic PDF, 755KB, File does not meet accessibility standards Date: 06. January 2026 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 60724/25

Urgent Field Safety Notice for Axios Stent and Delivery System by Boston Scientific Corporation Marlborough PDF, 2MB, File does not meet accessibility standards Date: 06. January 2026 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 61574/25

Urgent Field Safety Notice for Einwegpatientenschlauchsystem P3/P7 by Fritz Stephan GmbH PDF, 832KB, File does not meet accessibility standards Date: 06. January 2026 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 61742/25

Urgent Field Safety Notice for Efficia DFM100 by Philips Goldway (Shenzhen) Industrial Inc. PDF, 2MB, File does not meet accessibility standards Date: 06. January 2026 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 62888/25

Direct Healthcare Professional Communication (DHCP) on Tegretal Suspension (carbamazepine): Restriction on use in newborns, as the concentration of the excipient propylene glycol exceeds the recommended limit value. PDF, 235KB, File is accessible Date: 05. January 2026 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: carbamazepine

Novartis Pharma GmbH informs that Tegretal (carbamazepine) must not be used in newborns up to 4 weeks of age.

Urgent Field Safety Notice for CryoSure-DMSO by WAK-Chemie Medical GmbH PDF, 2MB, File does not meet accessibility standards Date: 05. January 2026 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 62368/25

Urgent Field Safety Notice for Medihoney by Derma Sciences, inc (in process in transitioning to Acell) PDF, 330KB, File does not meet accessibility standards Date: 05. January 2026 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - ointments and gels
Reference 36948/25

Urgent Field Safety Notice for Unterarmgehhilfe Klassiker by Ossenberg Vertriebs GmbH PDF, 706KB, File does not meet accessibility standards Date: 05. January 2026 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 58049/25

Urgent Field Safety Notice for Pilier provisoir by Implants Diffusion International S.A.R.L. PDF, 115KB, File does not meet accessibility standards Date: 03. January 2026 Topics: Medical devices Type: Customer information

Product group Dental products - dental implants
Reference 51534/25

Urgent Field Safety Notice for Abre Venous Self-expanding Stent System by Medtronic Inc PDF, 2MB, File does not meet accessibility standards Date: 31. December 2025 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 57951/25