Summary of Field Safety Notices July 2026

19/08/2026
Medical devices Summary of field safety notices (FSN)

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

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


Documents

Arkray ADAMS 8190V - Arkray - Field Safety Notice - 28 July 2026 - Advice regarding the use of the device PDF : 228KB | 28/07/2026 Abiomed Impella Introducer Kits 14Fr and 23Fr - Field Safety Notice - 30 June 2026 - Advice regarding leakage PDF : 317KB | 30/06/2026 Atellica CH Urine Albumin - Field Safety Notice - 6 July 2026 - Advice regarding product discontinuation PDF : 233KB | 06/07/2026 BD® neXus Disposable Infusion Set-Medcaptain life sciences co.ltd- Field Safety Notice- 15 July 2026- Product removal PDF : 423KB | 15/07/2026 BLEPHADEMODEX – Theapharma – Field Safety Notice – 07 July 2025 - Advice regarding the use of the device PDF : 171KB | 07/07/2026 Beckman Coulter Chemistry Analyzer AU480 - Field Safety Notice - 31 July 2026 - Advice regarding the use of the device PDF : 464KB | 31/07/2026 Connecting Rod Hoffmann® II Micro - Field Safety Notice - 14 July 2026 - Advice regarding product removal PDF : 504KB | 14/07/2026 CS100 and CS300 Intra-Aortic Balloon Pumps - Datascope Corp. - Field Safety Notice - 24 June 2026 - Advice regarding changes updates made to instructions for use PDF : 167KB | 24/06/2026 Esteem Body™ Soft-Tap Convex Urostomy Pouch-Convatec-Field Safety Notice-July 2026- Advice regarding device removal PDF : 300KB | 31/07/2026 Flow devices, Maquet Critical Care AB-Field Safety Notice-01 July 2026- Advise regarding use of device and future software update PDF : 247KB | 01/07/2026 KayserBett OLAF and KayserBett Mascot - Field Safety Notice - 3 July 2026 - Change of hand control PDF : 115KB | 03/07/2026 Mequ M Warmer-Follow Up Field Safety Notice-25 June 2026-Extension of Initial Recall PDF : 564KB | 25/06/2026 EOPA Arterial Cannulae-Field Safety Notice-24th June 2026-Product removal due to pinhole leaks PDF : 278KB | 24/06/2026 EntericBio Viral Panel 1,2 and 3 - Field Safety Notice - 7 July 2026 - Pouches are not fully heat sealed PDF : 576KB | 07/07/2026 Embosphere® Microspheres – Field Safety Notice – 31 July 2026 – Recall of devices with packaging defect PDF : 452KB | 31/07/2026 Drying Cabinet S-363 - Getinge - Field Safety Notice – 14 July 2026 - Advice regarding a device modification PDF : 428KB | 14/07/2026 GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) - W. L. Gore & Associates, Inc. - Field Safety Notice - 28th July 2026 - Advice regarding changes updates made to instructions f PDF : 181KB | 28/07/2026 HOTLINE™ Fluid Warming Sets- Field Safety Notice-09 July 2026-Advice on device removal due to leakage issue PDF : 350KB | 09/07/2026 Hemospray Endoscopic Hemostat - Cook Endoscopy Wilson Cook Medical, Inc. - Field Safety Notice - 04 August 2026 - Advice regarding changes updates made to instructions for use PDF : 249KB | 04/08/2026 MEDSTOP - Field Safety Notice - 7 July 2026 - IFU Updates to clearly communicate safety information PDF : 461KB | 07/07/2026 MiniMed™ 600 & 700 series Insulin Pumps- Field Safety Notice- July 2026- Retrieval of loaner devices PDF : 134KB | 31/07/2026 Multiva 1.5T - Updated Field Safety Notice - 26 June 2026 - Software update and follow-up correction PDF : 439KB | 26/06/2026 Neisseria meningitidis Gp C 2mlVL - Field safety notice - 16 July 2026 - Advice regarding a device removal PDF : 384KB | 16/07/2026 Panocell 16 - Field Safety Notice - 20 July 2026 - Advice regarding the use of a device PDF : 240KB | 20/07/2026 Philips Cardiac Workstation 5000 and 7000 - Field Safety Notice - 13 July 2026 - Potential incorrect measurements when putting the device in and returning the device from 'standby' mode PDF : 314KB | 13/07/2026 Philips Azurion R3.1 Systems - Field Safety Notice - 16 July 2026 - Potential for image quality degradation and or loss of geometry movements PDF : 384KB | 16/07/2026 Philips Allura and Azurion systems - Field safety Notice - 17 June 2026 - Potential hard disk drives out of specification PDF : 347KB | 17/07/2026 Philips Allura R8.2 systems - Philips Medical Systems - Field Safety Notice - 3 July 2026 - Advice regarding a software upgrade PDF : 372KB | 03/07/2026 Philips Azurion R2.x.10 Systems - Field Safety Notice - 16 July 2026 - Potential for image quality degradation and or loss of geometry movements PDF : 393KB | 16/07/2026 Percutaneous Insertion Kits (PIK) - Maquet Cardiopulmonary GmbH - Field Safety Notice - 27 July 2026 - Advice regarding a device removal PDF : 309KB | 27/07/2026 OverStitch™ Suture Cinch and Suture Cinch–Long - Boston Scientific Corporation - Field Safety Notice - 14 July 2026 - Advice regarding a product removal PDF : 272KB | 14/07/2026 nli and Infyna Hydrophilic Intermittent Catheter-Field Safety Notice-6th of July-Instructions regarding use of device due to protrusions PDF : 366KB | 06/06/2026 Shenzhen Mindray Monitors - Field Safety Notice - 20 July 2026 - Advice regarding update to the IFU PDF : 183KB | 20/07/2026 Single Use Distal Cover - Olympus - Field Safety Notice - 30 June 2026 - Advice regarding a device removal PDF : 468KB | 30/06/2026 Sphere-9 Catheter - Medtronic, Inc. - Field Safety Notice - 01 July 2026 - Advice regarding changes updates made to instructions for use PDF : 308KB | 30/06/2026 Spacelabs Healthcare Xhibit Central Station - Field safety Notice - 04 June 2026 - Device Modification for new splitter to prevent potential loss of audio and visuals PDF : 172KB | 04/06/2026 Sonopet 12cm iQ Claw - Stryker Instruments - Field Safety Notice - 10 June 2026 - Advice regarding a device removal PDF : 241KB | 10/06/2026 Soluscope ENT washer‑disinfectors - Soluscope - Field Safety Notice - 7 July 2026 - Advice regarding use of device (2) PDF : 280KB | 12/05/2026 Soluscope ENT washer‑disinfectors - Soluscope - Field Safety Notice - 7 July 2026 - Advice regarding use of device PDF : 215KB | 12/05/2026 Silver Graft (Helix) Vascular Prosthesis - Field Safety Notice - 24 July 2026 - Advice regarding update to the IFU PDF : 8.42MB | 09/07/2026 Various Hyaltech Ltd devices – Hyaltech Ltd (Carl Zeiss Meditech) – Field Safety Notice - 4 August 2026 - Advice regarding a device removal PDF : 1.33MB | 04/08/2026 STA Staclot Protein S - Field Safety Notice - Advice regading lot removal PDF : 4.17MB | 20/07/2026 THERAKOS® CELLEX® Photopheresis Procedural Kit-Field Safety Notice-16 June2026-Prodcut recall- potential for improper installation PDF : 295KB | 16/06/2026 The Eye Doctor Advanced Triple Action Eye Drops 10ml - Field safety Notice - 6 July 2026 - Advice regarding stolen devices PDF : 460KB | 20/07/2026 TD Navio Midi - Maxi - Dynavox Group AB - Field Safety Notice - 10 July 2026 - Advice regarding a device modification PDF : 168KB | 10/07/2026 Surgipro™, Surgipro II™, Dermalon™, V-Loc™ 90, V-Loc™ 180 sutures - Covidien LLC - Field Safety Notice - 7 July 2026 - Advice regarding a device removal PDF : 275KB | 31/07/2026 Suction Connecting Tubing - Field Safety Notice - 16 July 2026 - Moulding imperfections leading to compromised device performance PDF : 175KB | 20/07/2026 Sphere-360 Catheter - Medtronic, Inc. - Field Safety Notice - 13 July 2026 - Advice regarding the use of the device PDF : 138KB | 31/07/2026