Summary of Field Safety Notices April 2026

05/05/2026
Medical devices Summary of field safety notices (FSN)

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

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

Documents

Avantgarde 4 and Zenit_Ottobock_Advice regarding the use of the device PDF : 243KB | 31/03/2026 Bobby Balloon Guide Catheter_MicroVention_Advice regarding a device removal PDF : 286KB | 30/04/2026 Aural Ventilation Tubes_Exmoor Plastics Limited_Advice Regarding Device Removal PDF : 619KB | 22/04/2026 Arrow Haemodialysis Kits&sets_Teleflex inc._Recall PDF : 1.03MB | 26/04/2026 Bossklein & Unodent Alcohol Free Surface Disinfectant Wipes_Topdental Products Ltd_Advice regarding a device removal PDF : 364KB | 15/04/2026 da Vinci X & Xi Surgical System_Intuitive Surgical, Inc._Advice regarding a device modification PDF : 247KB | 30/04/2026 Dexcom G7 iOS CGM App_Dexcom_Advise of software update PDF : 146KB | 30/04/2026 DexcomONE iOS CGM App_Dexcom_Advise on software update PDF : 143KB | 30/04/2026 InZone Detachment System_Stryker Neurovascular_Advice regarding a device removal PDF : 311KB | 30/04/2026 Intrauterine Tubes 4mm_Nucletron B.V._Advice regarding the use of the device PDF : 221KB | 30/04/2026 Impella Purge Cassette Generation 1_Abiomed_Advice regarding a device removal PDF : 855KB | 31/03/2026 Intracept Access Instruments_Boston Scientific Neuromodulation Corporation_Advice regarding a device removal PDF : 286KB | 24/04/2026 Infinity Implantable Pulse Generator_Abbott Medical_Advice regarding the use of the device PDF : 269KB | 26/04/2026 HS55, HS66, GE small, GEV small_GETINGE STERILIZATION AB_Advice Regarding Use of a Device PDF : 233KB | 30/04/2026 HemosIL Heparin Calibrators_Werfen_Advice regarding the use of the device PDF : 142KB | 04/03/2026 HALYARD PUREZERO Ultraviolet Nitrile Exam Gloves_Owens and Minor Halyard Inc._Advice regarding a device removal PDF : 240KB | 10/04/2026 i-STAT EG7 and EG6 cartridge_Abbott Point Of care_Advice regarding a lot removal PDF : 220KB | 31/03/2026 Merivaara Q Flow surgical lights_Merivaara Corporation_Advice regarding the use of the device PDF : 366KB | 31/03/2026 Merit SplashWire® Hydrophilic Steerable Guide Wire_Merit Medical Systems, Inc._Advice regarding a device removal PDF : 334KB | 31/03/2026 Merivaara Q Flow surgical lights_Merivaara Corporation_Annex 1 Repair Guidance PDF : 331KB | 24/04/2026 Merivaara Q Flow surgical lights_Merivaara Corporation_Annex 2_Annual Maintenance Inspection Form PDF : 142KB | 31/03/2026 M Zn Air Battery Pak_Advanced Bionics LLC_Advice Regarding Device Removal PDF : 474KB | 23/03/2026 Merivaara Q Flow surgical lights_Merivaara Corporation_Customer Reply Form PDF : 191KB | 31/03/2026 Namic RA Syringes in Medline Fluid Management kits or procedure packs_Medline Industries, LP_Advice regarding a device removal PDF : 539KB | 09/04/2026 Namic White star Handle Manifolds_Medline_expansion of scope_updated FSN_Recall PDF : 314KB | 30/03/2026 Namic RA Syringes in Medline Non Sterile Fluid Management kits_Medline Industries, LP_Advice regarding a device removal PDF : 434KB | 09/04/2026 Namic RA Syringes_Medline Industries, LP_Advice regarding a device removal PDF : 416KB | 09/04/2026 Namic White Star Handle Manifolds_Medline_recall PDF : 314KB | 30/03/2026 NAVIFY Digital Pathology_Ventana Medical Systems Inc._Advice Regarding a Software Upgrade PDF : 638KB | 23/04/2026 PALAMIX® uno and PALAMIX® duo_Heraeus Medical GmbH_Advice regarding the use of the device PDF : 157KB | 20/03/2026 Panocell & Capture-R Ready-ID Extend II_Werfen (Immucor)_Advice regarding the use of the device PDF : 237KB | 01/04/2026 Philips Allura and Azurion Systems_Philips Medical Systems_Advice regarding a device modification PDF : 220KB | 24/04/2026 TDC VELOCE™_D.O.R.C. Dutch Ophtalmic Research Center (International) B.V._ Advice regarding a device removal PDF : 149KB | 30/04/2026 SynchroMed™ Flex Infusion Mode - A810 Clinician Programmer Software Application_Medtronic_Advice on the use of device PDF : 266KB | 30/04/2026 Swan Ganz Catheters_BD Advanced Patient Monitoring_Advice regarding the use of the device PDF : 303KB | 30/04/2026 Siliconeglue_VYGON Germany GmbH_Advice Regarding Device Removal PDF : 487KB | 22/04/2026 Proclaim Implantable Pulse Generators_Abbott Medical_Advice regarding the use of the device PDF : 290KB | 30/04/2026 POLARx & POLARx FIT,POLARSHEATH, SMARTFREEZE_Boston Scientific Corporation_Advice regarding a device removal PDF : 228KB | 09/04/2026 PHYSICA ZUK ARTICULAR SURFACES_Limacorporate SPA_Advice regarding a device removal PDF : 643KB | 14/04/2026 Philips Azurion Systems_Philips Medical Systems_Advice regarding a device modification PDF : 253KB | 24/04/2026 Various product types_ Cook Medical Incorporated Attachment 1 – Product Information Table PDF : 96KB | 05/03/2026 Trilogy EVO Trilogy EVO 02 Trilogy EV300_Philips Respironics_Advice regarding use of device_Follow up PDF : 334KB | 13/04/2026 Various product types_Cook Medical incorporated_advise on device removal PDF : 183KB | 25/03/2026 3Dimensions™ and Selenia® Dimensions® Mammography Systems_Hologic, Inc._Advice regarding updates made to maintenance inspection procedure PDF : 166KB | 25/03/2026 °M Warmer_MEQU_Advice on Device removal PDF : 1.19MB | 31/03/2026 8mm SureForm 30 Gray Reload_Intuitive Surgical Inc._Advice regarding a device removal PDF : 709KB | 30/04/2026