Summary of Field Safety Notices June 2026

03/07/2026
Medical devices Summary of field safety notices (FSN)

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

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

Documents

STARR Surgical ICL TICL Calculator IOD Software - Field Safety Notice Follow Up - 4 June 2026 - Additional Issues Identified that may affect information displayed on IOD PDF : 193KB | 03/07/2026 Olympus Ellik Evacuator-Field Safety Notice-16 June 2026-Missing Sterilization Validation Data and Invalid IFU Sterilization Cycles PDF : 252KB | 03/07/2026 SCS Infinion CX Lead - Field Safety Notice - 17 June 2026 - Advice regarding a device removal PDF : 225KB | 03/07/2026 Nephomax - Field Safety Notice - 23 June 2026 Advice regarding use of device PDF : 304KB | 03/07/2026 MEDUMAT Standard2 Grundgerät_Field Safety Notice-05 June 2026- Undetected leaks and disconnections PDF : 1.31MB | 03/07/2026 Radial Jaw 4 Biopsy Forceps - Field Safety Notice - 30 June 2026 - Potential breach in the sterile barrier of the device packaging PDF : 276KB | 03/07/2026 Intersurgical One- piece Guedel airway- Field Safety Notice-05 June 2026- Occluded or partially occluded tips PDF : 864KB | 03/07/2026 Integra® Omni-Tract® Table Mounted Retractor System - Field safety notice - 15 June 2026 - Extended drying time post sterilisation cycle PDF : 417KB | 03/07/2026 DLP One-Piece Pediatric Arterial Cannula and Bio-Medicus Adult Cannula Kit - Field Safety Notice - 4 June 2026 - Potential blood contamination PDF : 280KB | 03/07/2026 High Flow Insufflation Unit - Field Safety Notice - 16 June 2026 - Increase in UHI-4 front-panel ‘blackout’ complaints PDF : 180KB | 03/07/2026 HarmonyAIR A-Series Surgical Lighting Systems - Field Safety Notice - 19 May 2026 - Potential detachment of buttons on light heads PDF : 236KB | 03/07/2026 BiPAP A30, BiPAP A30 Hybrid, BiPAP A40 - Field Safety Notice follow up Rev G - 9 May 2026 Ventilator Inoperative Alarm condition PDF : 498KB | 03/07/2026 CASE v7 Thermal Printer Assembly - Field Safety Notice - 12 May 2026 - Potential for electrical sparking at the printer head PDF : 205KB | 03/07/2026 Custom Tubing Packs (CTPs)- Field Safety Notice - 22 June 2026 - Potentially compromised sterile barrier PDF : 383KB | 03/07/2026 NeoSpan® SuperElastic Compression Staple w Instruments - Field Safety Notice - 8 May 2026 - Missing MR conditional symbol in packaging PDF : 318KB | 03/07/2026 Lifecodes LSA Class II Kit - Field Safety Notice - 19 June 2026 - Advice regarding Use of the Device PDF : 279KB | 03/07/2026 Biocartis NV_Idylla MSI Test _Advice regarding the review of patient resultspatient recallsample restesting is required PDF : 546KB | 03/07/2026 FARASTAR Pulsed Field Ablation Generator - Field Safety Notice - 11 June 2026 - Labelling issues PDF : 192KB | 03/07/2026 CyberKnife - Field Safety Notice - 28 May 2026 - Advice regarding a software update PDF : 244KB | 03/07/2026 FARADRIVE Steerable Sheath - Field Safety Notice - 11 June 2026 - Update to Instructions for Use PDF : 266KB | 03/07/2026 ApexPro CARESCAPE Telemetry Server - Field safety notice - 27 May 2026 - Potential loss of monitoring PDF : 136KB | 03/07/2026 EVOQUE Tricuspid Delivery System - Field safety notice - 26 May 2026 - Potential resistance when rotating the capsule or inability to retract capsule PDF : 167KB | 03/07/2026 Aquaflush Transanal Irrigation System - Field Safety Notice - 12 June 2026 - Advice regarding recall of products PDF : 383KB | 03/07/2026 Baxter Healthcare SA_Homechoice Automated PD Set with Cassette_Advice regarding device removal_Home users PDF : 535KB | 03/07/2026 AirSeal® Access Ports - Field Safety Notice - 24 June 2026 - IFU updates to avoid erroneous overpressure alerts through secure connection PDF : 365KB | 03/07/2026 Baxter Healthcare SA_Homechoice Automated PD Set with Cassette_Advice regarding device removal_For HCP PDF : 578KB | 03/07/2026 Automated Impella Controller - Field Safety Notice - 1 July 2026 - Advice regarding a potential device restart PDF : 303KB | 03/07/2026