Field Safety Notices: 18  to 22 August 2025
Source: gov.uk (2025-08-26)

List of Field Safety Notices from 18 to 22 August 2025.

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs (https://mhra-gov.filecamp.com/s/o/lUsUOl3o3xCC06LL)

View a list of FSNs published since January 2020 (https://mhra-gov.filecamp.com/s/9g5cLjjFatXruS5U/d)

View FSNs since November 2014 (https://mhra-gov.filecamp.com/s/ZOxdOzRzP22RziUW/fo). FSNs before this date are on the National Archives website (https://webarchive.nationalarchives.gov.uk/*/http:/www.mhra.gov.uk/index.htm)

Alcon Laboratories, Inc: Alcon Standalone Vitrectomy Consumables

11th August 2025

Model: See Attached Affected Products

MHRA reference: 36497952 (https://mhra-gov.filecamp.com/s/d/04wytcUSgGAeMrjq) 2025/008/011/601/070

Baxter Medical Systems GmbH + Co. KG: TruSystem 7000

22nd July 2025

Universal Operating Table, Electromechanical

Model: 2065385, 1841046, 1841048

MHRA reference: 36501578 (https://mhra-gov.filecamp.com/s/d/UWBHStJnrl6ejBp8) 2025/007/xx-xxxx-xxxx

Bürki inno med AG: Bimanual I/A System single use

13th August 2025

Ophthalmic surgical instrument handle, single use

Model: BSD 515

MHRA reference: 36496391 (https://mhra-gov.filecamp.com/s/d/scyoCDnPaM7mz8Vq) 2025/008/007/601/024

DISOP, S.A : SEE FSN

3rd June 2025

Model: SEE FSN

MHRA reference: 36521442 (https://mhra-gov.filecamp.com/s/d/X2XTw991pWmVanNe)

Drägerwerk AG ; Co. KGaA : Atlan Family

August 2025

Anesthesia Units

Model: 8621100, 8621300, 8621400, 8621500, 8621600

MHRA reference: 36488827 (https://mhra-gov.filecamp.com/s/d/iJIBLPtVWb1CeQQP) 2025/008/018/601/072

Epocal Inc.: epoc Host 2 and epoc NXS Host

December 2022

Metabolic profile clinical chemistry analyser IVD

MHRA reference: 36510967 (https://mhra-gov.filecamp.com/s/d/wb31HAifZ6BRryPh) 2022/012/xx-xxxx-xxxx

GE Healthcare: Enterprise Archive

FMI 85486

Please see section 8 Comments

MHRA reference: 36501269 (https://mhra-gov.filecamp.com/s/d/9DCD9qSWnuj7Vf8p) 2025/008/019/601/068

Getinge Disinfection AB. : Getinge 88-series

15th August 2025

Surgical Utensil Washer/Disinfector

Model: 88-Turbo

MHRA reference: 36512382 (https://mhra-gov.filecamp.com/s/d/5ABTCg058t36IZlL) 2025/008/xx-xxxx-xxxx

Heraeus Medical Components-Contract Medical International GmbH : blueflow Venous Stent

14th August 2025

Bare-metal peripheral venous stent

MHRA reference: 36486730 (https://mhra-gov.filecamp.com/s/d/ei7VSfYSXSoHRdW4) 2025/008/015/601/030

Heraeus Medical Components-Contract Medical International GmbH : Fortress Introducer Sheath System

15th July 2025

Model: 6F Straight 45c

MHRA reference: 36488569 (https://mhra-gov.filecamp.com/s/d/5FZ8O6VPFWqjqdVV) 2025/007/xx-xxxx-xxxx

KLS Martin SE ; Co. KG: RECONPLATE 26-HOLE PREFORM. LEFT T=3,0

19th August 2025

Craniofacial fixation plate, non-bioabsorbable, no

MHRA reference: 36508301 (https://mhra-gov.filecamp.com/s/d/rlFnvIORBBrQRmk1) 2025/008/xx-xxxx-xxxx

Maquet Cardiopulmonary GmbH : see 8 Comments

12th June 2025

Trolley, medical device

Model: see 8 Comments

MHRA reference: 36501805 (https://mhra-gov.filecamp.com/s/d/97VK4EtHDfIvrm8A) 2025/006/013/601/064

Olympus Medical Systems Corporation: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

18th October 2024

Flexible video gastroduodenoscope

Model: GIF-1TH190

MHRA reference: 36507522 (https://mhra-gov.filecamp.com/s/d/biyqm2l7TQALygrF) 2025/008/001/601/007

SERF: NOVAE CI E

25th June 2025

Model: CI 43/22.2 E and CI 51/22.2 E

MHRA reference: 36497788 (https://mhra-gov.filecamp.com/s/d/e1Va3wCwrMyKNGRR) 2025/008/019/601/019

Siemens Healthcare Diagnostics Products GmbH : INNOVANCE VWF Ac

June 2025

MHRA reference: 36496667 (https://mhra-gov.filecamp.com/s/d/o2AD7Ry8qp5M0D1X) 2025/007/004/601/047

Spinal Kinetics LLC : M6-C Artificial Cervical Disc

13th August 2025

MHRA reference: 36496358 (https://mhra-gov.filecamp.com/s/d/2jluLOk37Xs5ZOoM) 2025/008/018/601/035