Field Safety Notices: 18 to 22 August 2025
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Alcon Laboratories, Inc: Alcon Standalone Vitrectomy Consumables
11th August 2025
Model: See Attached Affected Products
MHRA reference: 36497952 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 2025/007/022/601/060
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 2025/008/007/601/024
DISOP, S.A : SEE FSN
3rd June 2025
Model: SEE FSN
MHRA reference: 36521442
Drägerwerk AG ; Co. KGaA : Atlan Family
August 2025
Anesthesia Units
Model: 8621100, 8621300, 8621400, 8621500, 8621600
MHRA reference: 36488827 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 2022/012/023/601/006
GE Healthcare: Enterprise Archive
FMI 85486
Please see section 8 Comments
MHRA reference: 36501269 2025/008/019/601/068
Getinge Disinfection AB. : Getinge 88-series
15th August 2025
Surgical Utensil Washer/Disinfector
Model: 88-Turbo
MHRA reference: 36512382 2025/008/020/601/046
Heraeus Medical Components-Contract Medical International GmbH : blueflow Venous Stent
14th August 2025
Bare-metal peripheral venous stent
MHRA reference: 36486730 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 2025/007/025/601/052
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 2025/008/020/601/006
Maquet Cardiopulmonary GmbH : see 8 Comments
12th June 2025
Trolley, medical device
Model: see 8 Comments
MHRA reference: 36501805 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 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 2025/008/019/601/019
Siemens Healthcare Diagnostics Products GmbH : INNOVANCE VWF Ac
June 2025
MHRA reference: 36496667 2025/007/004/601/047
Spinal Kinetics LLC : M6-C Artificial Cervical Disc
13th August 2025
MHRA reference: 36496358 2025/008/018/601/035