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15.09.2025
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Urgent Field Safety Notice for FreeStyle Libre 3 Plus by Abbott Diabetes Care Ltd. UK
Product group Medical electronics / Electromedical devices -
electric blood glucose meters
Reference 42777/25
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16.09.2025
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Urgent Field Safety Notice for Heater Unit HU35 by Maquet Cardiopulmonary AG
Product group Surgical equipment/ Anaesthesia -
surgical equipment
Reference 43846/25
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16.09.2025
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Urgent Field Safety Notice for Sharesource Claria Connectivity Platform (Product Code 5CGM01 by Baxter Healthcare S. (Opfikon)
Product group Injections / Infusions / Transfusions / Dialysis -
dialysis technology
Reference 41831/25
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16.09.2025
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Finasteride- and dutasteride-containing medicines: suicidal thoughts and behaviours
Active substance: finasteride, dutasteride
The Federal Institute for Drugs and Medical Devices (BfArM) implements the final decision of the EU Commission nationally.
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18.09.2025
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Urgent Field Safety Notice for CellMek SPS by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
equipment / products for clinical chemistry
Reference 43191/25
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18.09.2025
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Urgent Field Safety Notice for MADSEN AccuScreen TEAOE/DPOAE/ABR Probe by PATH MEDICAL GmbH
Product group Medical electronics / Electromedical devices -
ENT equipment
Reference 43282/25
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18.09.2025
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Urgent Field Safety Notice for AIRVO2 Humidifier / myAIRVO2 Humidifier by Fisher & Paykel Healthcare Ltd
Product group Surgical equipment/ Anaesthesia -
anaesthesia and medical gas supply
Reference 43871/25
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18.09.2025
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Urgent Field Safety Notice for TactiFlex Force Sensing Ablation Catheter, S. by Abbott Plymouth, Product Performance Group
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 43964/25
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18.09.2025
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Urgent Field Safety Notice for Inogen Rove 4 Portable Oxygen Concentrator by Inogen, Inc.
Product group Physical therapy -
equipment for oxygen therapy
Reference 44123/25
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18.09.2025
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Urgent Field Safety Notice for Catalyft PL Expandable Interbody System by Medtronic Sofamor Danek Inc.
Product group Non-active implants -
bone surgery
Reference 44690/25
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18.09.2025
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Urgent Field Safety Notice for BRONCHOVIDEOSCOPE and BRONCHOFIBERSCOPE, divers by Olympus Medical Systems Corp.
Product group Optics / Precision engineering -
endoscopes
Reference 42982/25
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22.09.2025
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Causes of death coding in Iris with ICD-11 testing results
Causes of death coding in Iris with ICD-11 testing results
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22.09.2025
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Urgent Field Safety Notice for OSSURE Local Osteo-Enhancement Procedure (LOEP) Kit by AgNovos Healthcare USA, LLC
Product group Non-active implants -
materials for implants
Reference 27339/25
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22.09.2025
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Urgent Field Safety Notice for Helix GM Implant 4.3X10.0 Acqua by JJGC Indústria e Co.ércio de Materiais Dentários S.A.
Product group Dental products -
dental implants
Reference 42701/25
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22.09.2025
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TOPRA Symposium 2025 in Berlin
TOPRA Symposium 2025 in Berlin - Timetable
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23.09.2025
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Urgent Field Safety Notice for FRED& FRED XFlow Re-Direction Endoluminal Device by MicroVention Europe
Product group Non-active implants -
special implants
Reference 44793/25
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23.09.2025
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Urgent Field Safety Notice for UROMED Silicone Balloon Catheter by UROMED Kurt Drews KG
Product group Injections / Infusions / Transfusions / Dialysis -
catheters
Reference 45261/25
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23.09.2025
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Urgent Field Safety Notice for UniCel DxH 900 COULTER Cellular Analysis System UniCel DxH 690T COULTER Cellular Analysis System UniCel DxH 800 COULTER Cellular Analysis System* UniCel DxH 600 COULTER Cellular Analysis System* FRU,LED HGB PHOTOMETER by Beckman Coulter, Inc.
Product group In-vitro diagnostics -
haematological, histological and cytological products
Reference 39570/25
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24.09.2025
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Urgent Field Safety Notice for ZENITH ALPHA 2 THORACIC ENDOVASCULAR GRAFT by William Cook Europe ApS
Product group Non-active implants -
special implants
Reference 44058/25
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24.09.2025
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Urgent Field Safety Notice for Certain Nuclear Medicine Systems by GE Medical Systems Israel, Functional Imaging
Product group Radiological technology -
equipment for nuclear medical functional and localisation diagnostics
Reference 44052/25
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