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Date Title:
29.08.2025 Urgent Field Safety Notice for FIAB electrodes for external defibrillation by FIAB SpA

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 39601/25

29.08.2025 Urgent Field Safety Notice for Option Rhinomanometry, Option SNIP by Jaeger Medical GmbH

Product group Medical electronics / Electromedical devices - pulmonary function diagnostics
Reference 38634/25

29.08.2025 Direct Healthcare Professional Communication (DHPC) on Lipidem emulsion for infusion: Subvisual agglomerates, use of an infusion filter for lipid emulsions

Active substance: soya bean oil, refined, medium-chain triglycerides, omega-3-acid triglycerides Braun Melsungen AG informs about agglomerates consisting of droplet-like structures that have been detected in individual batches of the medicinal product.

28.08.2025 Urgent Field Safety Notice for ARGUS PB-3000 by Schiller AG

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 37479/25

28.08.2025 Urgent Field Safety Notice for Troponin I Test (Triage) by Quidel Corporation

Product group In-vitro diagnostics - immunological products
Reference 40851/25

28.08.2025 Urgent Field Safety Notice for CADD Medication Cassette Reservoir by ICU Medical Inc

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 40521/25

27.08.2025 Urgent Field Safety Notice for 8-402 Atemtraining-Set by Flexicare Medical Limited

Product group Physical therapy - insufflation technique
Reference 21354/25

27.08.2025 Urgent Field Safety Notice for Tentos 4F by optimed Medizinische Instrumente GmbH

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 39287/25

27.08.2025 Urgent Field Safety Notice for ICEfx Cryoablation System by Boston Scientific Corporation Marlborough

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 39061/25

26.08.2025 Urgent Field Safety Notice for MEDRAD Centargo by Imaxeon Pty Ltd Imaxeon is a subsidiary company of Bayer

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 43923/24

26.08.2025 Urgent Field Safety Notice for Heartstring III (Proximales Versiegelungssystem; HST III System) by Maquet Cardiovascular LLC

Product group Medical instruments for use in humans - vascular surgery
Reference 40312/25

26.08.2025 Urgent Field Safety Notice for Alcon Standalone Vitrectomy Consumables by Alcon Laboratories, Inc.

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 38501/25

25.08.2025 Urgent Field Safety Notice for GORE ACUSEAL Vascular Graft by W. L. Gore & Associates, Inc.

Product group Non-active implants - special implants
Reference 39840/25

25.08.2025 Pharmacoepidemiology

Pharmacoepidemiology
22.08.2025 Urgent Field Safety Notice for VITROS Chemistry Products Performance Verifier I & II by QuidelOrtho (Ortho Clinical Diagnostics Inc)

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 27854/25

22.08.2025 Urgent Field Safety Notice for Op-Air One TIIR by MEDICOM SAS

Product group General equipment for medical treatment - auxiliary equipment
Reference 38680/25

22.08.2025 Urgent Field Safety Notice for ViziShot 2 Flex by Gyrus ACMI Inc.

Product group Optics / Precision engineering - endoscopes
Reference 37682/25

22.08.2025 Direct Healthcare Professional Communication (DHPC) on Amversio 1 g powder for oral administration: Wrong PZN encoded in the 2D barcode

Active substance: betaine SERB Pharmaceuticals has reported that three batches were packaged for the German market with a faulty PZN number in the NTIN-DE and in the 2D barcode.

21.08.2025 Urgent Field Safety Notice for Exactech Equinoxe Humeral Liners by EXACTECH, Inc.

Product group Non-active implants - bone surgery
Reference 39736/25

21.08.2025 Urgent Field Safety Notice for Enterprise Archive by GE Healthcare

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 39630/25