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Summary of Field Safety Notices February 2026

04/03/2026
Medical devices Summary of field safety notices (FSN)

We have published a monthly summary of Field Safety Notices (FSN) affecting the Irish market for February 2026 below. 

The naming convention for each document is <product name><manufacturer name><type of action taken by manufacturer.


Documents

Opens in new window 16F Dual-Valved Splittable Sheath Introducer_Merit Medical _Advise for device removal PDF : 304KB | 18/02/2026 Opens in new window Alfinion HbA1C – Abbot Diagnostic Technologies – Advice regarding use of the device PDF : 362KB | 04/02/2026 Opens in new window ArmStrong Medical Ltd – Ventilator Circuit – Advice regarding device removal – Follow up PDF : 231KB | 19/12/2025 Opens in new window Cobas Pro and Pure Sample Supply Unit – Roche Diagnostics – Advice regarding use of the device PDF : 118KB | 18/02/2026 Opens in new window Centricity Universal Viewer Zero Footprint Client – GE Healthcare – Advice regarding use of the device PDF : 187KB | 27/02/2026 Opens in new window BiPAP A40 Pro ventilators – Philips Respironics – Advice regarding removal of the device PDF : 282KB | 09/02/2026 Opens in new window CellAED_RapidResponseRevival Manufacturing Pty Ltd_Advice regarding the use of the device PDF : 462KB | 29/01/2026 Opens in new window Esteem Body_ Convatec_ Advice regarding device removal PDF : 309KB | 26/02/2026 Opens in new window Panocell-20_Immucor Inc (Werfen)_Advice regarding the use of the device PDF : 235KB | 21/01/2026 Opens in new window LIFECODES LSA Class I_Immucor GTI Diagnostic Inc_Advice regarding the use of the device PDF : 214KB | 04/02/2026 Opens in new window IMACTIS® CT-Navigation™ System – IMACTIS SAS – Advice regarding changes made to instructions for use PDF : 117KB | 27/02/2026 Opens in new window HistoPot 180ml_Serosep Limited_Advice regarding the use of the device PDF : 519KB | 17/02/2026 Opens in new window Hugo RAS Wristed Instruments - Bipolar Fenestrated Grasper and Bipolar Maryland Forceps_Covidien llc_Advice regarding the use of the device PDF : 203KB | 27/02/2026 Opens in new window Flexible cryoprobe, single-use_Erbe Elecktromedizin GmbH_Advice regarding a device removal PDF : 169KB | 12/02/2026 Opens in new window Draeger F120 ventilators_Fritz Stephan GmbH_Advise regarding maintanince of device PDF : 532KB | 28/11/2025 Opens in new window BD Alaris and Nexus Syringe Pumps_ BD_ Advice regarding use of the device PDF : 593KB | 11/02/2026 Opens in new window da Vinci X or Xi Reusable Instrument Grip Cables_ Intuitive Surgical, Inc._Advice regarding a device removal_Follow Up FSN PDF : 5.2MB | 27/02/2026 Opens in new window Instinct Plus Endoscopic Clipping Device – Cook Endoscopy Wilson Cook Medical, Inc. – Advice regarding device removal PDF : 324KB | 25/02/2026 Opens in new window DVI cables for Qube & Xprezzon_Spacelabs Healthcare_Advice regarding a device removal PDF : 114KB | 07/02/2026 Opens in new window MAJ 210 Single Use Biopsy Valve_Olympus Medical Systems Corporation_Advice regarding the use of the device PDF : 250KB | 24/02/2026 Opens in new window Philips Azurion Systems – Philips Medical Systems – Advice regarding updates made to instructions for use PDF : 369KB | 26/01/2026 Opens in new window Philips Respironics Inc – Trilogy EVO Trilogy, EVO O2, Trilogy EV300 – Advice regarding software update PDF : 356KB | 09/02/2026 Opens in new window Integra LifeScience – CUSA ® Clarity Console C7000 – Advice regarding a software upgrade PDF : 627KB | 24/02/2026 Opens in new window Ringlight fiber and Ringlight Slim Fiber – LSO Medical name – Advice regarding device removal – Follow up FSN 2 PDF : 296KB | 13/01/2026 Opens in new window GEM Premier 5000 PAK_Instrumentation Laboratory Co (Werfen)_Advice Regarding the use of the device PDF : 8.86MB | 20/01/2026 Opens in new window Zimmer® Air Dermatome and Zimmer® Dermatome AN_Zimmer Surgical_Advice regarding a device removal_Follow Up FSN PDF : 540KB | 06/02/2026 Opens in new window STA Liatest Free Protein S 6ml_Diagnostica Stago France_Advice regarding a device removal PDF : 283KB | 22/01/2026 Opens in new window STA LIATEST DDI PLUS_Diagnostica Stago_Advice regarding the use of the device PDF : 328KB | 03/02/2026 Opens in new window Xpert Carba-R_Cepheid_Advice regarding the use of the device PDF : 175KB | 09/01/2026