Summary of Field Safety Notices January 2026

09/02/2026
Medical devices Summary of field safety notices (FSN)

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

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

Documents

ACE® Cup Introducer M7_JRI Orthopaedics Ltd_Advice regarding the use of the device PDF : 665KB | 17/12/2025 AlarisTM VP Infusion Sets _BD Switzerland_Advice regarding device removal PDF : 361KB | 21/01/2026 Aquasil putty Soft and Hard Long setting time_Dentsply Sirona_Advice regarding the use of the device PDF : 241KB | 29/01/2026 Armstrong Medical Ltd._Ventilator Circuit_Advice regarding changes made to instructions for use PDF : 159KB | 19/12/2025 Atellica CH Urine Albumin (UAlb)_Siemens Healthcare Diagnostics Inc_Advice regarding the use of the device PDF : 231KB | 30/01/2026 AU5800 and DxC 700 AU clinical chemistry analyzers_Beckman Coulter_Advice regarding the use of the device PDF : 610KB | 27/01/2026 AXIOS™ Stent and Delivery System_Boston Scientific Corporation_Advice regarding a device removal PDF : 608KB | 19/12/2025 Baxter Healthcare SA_EVO IQ Large Volume Pump_Advice regarding a device modification PDF : 182KB | 28/01/2026 CryoSure-DMSO, WAK-DMSO-70_WAK-Chemie Medical GmbH_Advice regarding the use of the device PDF : 374KB | 19/12/2025 cobas pro Sample supply unit, cobas pro SSU, cobas pure sample supply unit_Hitachi High Technologies Corporatio Roche Diagnostics GmbH_Advice Regarding the use of the device PDF : 0KB | 30/01/2026 Cobas Hb1A1c Test Gen 2_Roche Diagnostics GmbH_Advice regarding a device removal PDF : 28KB | 23/12/2025 CleverCut and FlowCut Sphincterotomes_Olympus Medical Systems Corporation_Advice regarding a device removal PDF : 215KB | 30/01/2026 Chest Drainage Units & accessories_ Cardinal Health _Advice regarding the use of the device PDF : 156KB | 29/12/2025 Centricity RIS-i_GE Healthcase_Advice regarding a software update PDF : 200KB | 30/01/2026 Broviac Hickman Catheters_ Bard Access Systems_Advice regarding a device removal PDF : 363KB | 13/01/2026 Brevera® Breast Biopsy System Disposable 9 Gauge N_Hologic, Inc._Advice regarding a device removal PDF : 718KB | 07/01/2026 CS100 and CS300 Intra-Aortic Balloon Pumps_Datascope Corp._Advice regarding changes updates made to instructions for use PDF : 152KB | 30/01/2026 High Flow Insufflation Unit_Olympus Medical Systems Corporation_Advice regarding a device removal PDF : 169KB | 28/01/2026 ICU Medical Inc._Tego_Advice regarding a device removal PDF : 317KB | 15/01/2026 Klassiker Forearm Crutches_Ossenberg GmbH_Advice regarding a device modification PDF : 662KB | 18/12/2025 KWIK-STIK and LYFO DISK controls_Microbiologics_Updated FSN_Advice regarding a lot removal PDF : 333KB | 29/12/2025 Medihoney Barrier and Derma non-sterile creams_Derma Sciences inc_Advice regarding device recall PDF : 220KB | 08/01/2026 Medihoney Sterile_Derma Sciences inc_Advice Regarding a Device Recall PDF : 330KB | 29/12/2025 Medline International France SAS_Color coded syringes red and blue included in Medline Sterile procedure trays_Advice regarding device removal_Follow up PDF : 427KB | 30/01/2026 Sterile Surgical Drapes & Gowns_Medline International France SAS_Advice regarding a device removal PDF : 330KB | 30/01/2026 ShockPulse Lithotripsy Transducer & ShockPulse-SE Lithotripsy System_Gyrus ACMI, Inc. (Olympus Surgical Technologies America)_Advice regarding the use of the device PDF : 445KB | 12/01/2026 Resectoscopes Resection sheath; Inner Sheath; Sheath_Olympus Winter & Ibe GmbH_Advice regarding updates made to instructions for use PDF : 397KB | 30/01/2026 Raz-AT (Attendant Tilt) Mobile Shower Commode Chair_Raz Design Inc._Advice regarding a device modification PDF : 375KB | 26/01/2026 Prismaflex sets, Oxiris sets_Baxter Healthcare_Advice regarding the use of device PDF : 352KB | 12/01/2026 Outer sheath, 22.5 Fr. (for rigid cystoscopes)_Olympus Winter & Ibe GmbH_Advice regarding a device removal PDF : 183KB | 30/01/2026 Ophthalmic Soft-Tissue Manipulation Forceps_Vortex Surgical Inc_Advice regarding a device removal PDF : 186KB | 21/01/2026 MobileDiagnost wDR_Philips Medical Systems_Advice regarding a device modification PDF : 279KB | 30/01/2026 StrykeFlow 2 Suction Irrigator_Stryker Endoscopy_Advice regarding a device removal-Part 2 PDF : 300KB | 30/01/2026 Synchromed A810 Clinician programmer_Medtronic_Advide on software update PDF : 266KB | 30/01/2026 Thunderbeat_Olympus Medical Systems Corporation_Advice regarding a device removal PDF : 300KB | 08/01/2026 Triangle Tip Electrosurgical Knives_Olympus_Advice regarding the use of the device PDF : 220KB | 09/01/2026 Various Philips CT systems_Philips Medical Systems_Advice regarding a device modification PDF : 423KB | 06/01/2026 Venous Bubble Sensor_Maquet Cardiopulmonanry GmbH_Advice regarding the use of device PDF : 319KB | 16/12/2025 VITEK 2 AST Test Kit_bioMérieux Inc_Advice regarding the use of the device PDF : 389KB | 15/01/2026 ViziShot 2 FLEX (19G)_Olympus Surgical Technologies America_Advice regarding a device removal-all lots PDF : 255KB | 12/01/2026 Vyntus devices with SNIP option_Jaeger_Update on reprocessing instructions PDF : 363KB | 14/11/2025