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Oxbryta (voxelotor): Review of the benefit-risk ratio Date: 12. December 2025 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: voxelotor

With the publication of the European Commission's decision on 9 December 2025, the risk assessment procedure for Oxbryta (voxelotor) was completed. 

Urgent Field Safety Notice for Carestation 600 and 700 Series by Datex-Ohmeda, Inc. PDF, 622KB, File does not meet accessibility standards Date: 12. December 2025 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 58778/25

Urgent Field Safety Notice for DECALCIFIER DC1 Slow-acting Q PATH 5 L, FORMALIN 10% BUFFERED Q PATH(R) CUBI by VWR International SAS PDF, 130KB, File does not meet accessibility standards Date: 12. December 2025 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 56721/25

Urgent Field Safety Notice for FlexLab X by Inpeco SA PDF, 519KB, File does not meet accessibility standards Date: 12. December 2025 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 52059/25

Urgent Field Safety Notice for da Vinci Xi and da Vinci X Surgical System by Intuitive Surgical, Inc PDF, 198KB, File does not meet accessibility standards Date: 11. December 2025 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 53565/25

Urgent Field Safety Notice for IsoSeed I25.S16 by Eckert & Ziegler BEBIG GmbH PDF, 903KB, File does not meet accessibility standards Date: 11. December 2025 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - implantats emitting radioactive radiation
Reference 58876/25

Direct Healthcare Professional Communication (DHPC) on intravenous tranexamic acid formulations: Serious, including fatal, adverse reactions due to accidental intrathecal administration PDF, 879KB, File does not meet accessibility standards Date: 11. December 2025 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tranexamic acid

The marketing authorisation holders inform that injectable tranexamic acid formulations are only authorised for intravenous use.

Urgent Field Safety Notice for Incisive CT, CT 5300 by Philips Healthcare (Suzhou) Co.,Ltd PDF, 1MB, File does not meet accessibility standards Date: 10. December 2025 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 56698/25

Urgent Field Safety Notice for Synthes Cutting Tools by Synthes GmbH PDF, 636KB, File does not meet accessibility standards Date: 10. December 2025 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 57313/25

Urgent Field Safety Notice for EVER Pharma D-mine Pump Reservoir by Ever Neuro Pharma GmbH PDF, 568KB, File does not meet accessibility standards Date: 09. December 2025 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 57196/25

Urgent Field Safety Notice for Farbkodierte Spritze, 10 ml, LL, Polycarbonat, rot und blau enthalten im OP-Set by Medline International France SAS PDF, 1MB, File does not meet accessibility standards Date: 09. December 2025 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 56186/25

Urgent Field Safety Notice for F-120 DRÄGER by Fritz Stephan GmbH PDF, 1MB, File does not meet accessibility standards Date: 09. December 2025 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 53899/25

Urgent Field Safety Notice for ESOBLOCK Ø12mm by TEKNIMED PDF, 338KB, File does not meet accessibility standards Date: 05. December 2025 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 52569/25

Urgent Field Safety Notice for MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM by Aesculap AG PDF, 3MB, File does not meet accessibility standards Date: 05. December 2025 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - visceral surgery
Reference 57622/25

Urgent Field Safety Notice for Procedure packs (Kitpack) with MedNet syringes by Lohmann und Rauscher GmbH & Co. KG PDF, 1MB, File does not meet accessibility standards Date: 04. December 2025 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 56666/25

Urgent Field Safety Notice for Combur 10 Test M by Roche Diagnostics GmbH PDF, 108KB, File does not meet accessibility standards Date: 04. December 2025 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 55937/25

Urgent Field Safety Notice for Alinity ci-series System Control Module (SCM) by Abbott GmbH PDF, 416KB, File does not meet accessibility standards Date: 04. December 2025 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 54741/25

Urgent Field Safety Notice for Vanta Implantable Neurostimulator (INS) by Medtronic Inc PDF, 1,001KB, File does not meet accessibility standards Date: 04. December 2025 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 57515/25

Urgent Field Safety Notice for UniCel DxI 600; UniCel DxI 800 by Beckman Coulter, Inc. PDF, 245KB, File does not meet accessibility standards Date: 04. December 2025 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 57272/25

Urgent Field Safety Notice for Otesus by Maquet GmbH PDF, 201KB, File does not meet accessibility standards Date: 03. December 2025 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 56118/25

Urgent Field Safety Notice for LISA NE by FreiStil Tischlerei GmbH & Co. KG PDF, 957KB, File does not meet accessibility standards Date: 03. December 2025 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 56069/25

Urgent Field Safety Notice for CleanCell M by Roche Diagnostics GmbH PDF, 128KB, File does not meet accessibility standards Date: 03. December 2025 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 55975/25

Urgent Field Safety Notice for Kendall SCD 700 Sequential Compression System by Cardinal Health 200, LLC PDF, 622KB, File does not meet accessibility standards Date: 03. December 2025 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 50474/25

Urgent Field Safety Notice for FreeStyle Libre 3 and 3 Plus Sensor by Abbott Diabetes Care Ltd. UK PDF, 568KB, File does not meet accessibility standards Date: 02. December 2025 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electric blood glucose meters
Reference 55464/25

When will devices have to be registered in EUDAMED / when will the use of EUDAMED become mandatory? Date: 01. December 2025 Topics: Medical devices Type: FAQ

Products must continue to be registered in DMIDS until EUDAMED becomes mandatory on 28 May 2026. This will be followed by a six-month transition period, after which all MDR and IVDR products and legacy devices (still on the market on the date of …

Urgent Field Safety Notice for Intracranial Pressure Monitor Pressio®2 by Sophysa France PDF, 832KB, File does not meet accessibility standards Date: 01. December 2025 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 54884/25

Urgent Field Safety Notice for Vue PACS (Diagnostic) V12, Vue Motion V12 by Philips Medical Systems Nederland B.V. PDF, 687KB, File does not meet accessibility standards Date: 01. December 2025 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 56682/25

Urgent Field Safety Notice for Carescape One by GE Medical Systems Information Technologies, Inc. PDF, 569KB, File does not meet accessibility standards Date: 01. December 2025 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 56465/25

Urgent Field Safety Notice for ViewPoint 6 by GE Healthcare GmbH München PDF, 184KB, File does not meet accessibility standards Date: 01. December 2025 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 56691/25

Urgent Field Safety Notice for B125P/B105P/B125M/B105M/B155M Patient Monitor und Portrait VSM by GE Medical Systems Information Technologies, Inc. PDF, 573KB, File does not meet accessibility standards Date: 01. December 2025 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 56468/25