Field Safety Notices: 16 to 20 June 2025
List of Field Safety Notices from 16 to 20 June 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
Abbott Ireland Diagnostics Division: Alinity i Total PSA Reagent Kit
22 May 2025
MHRA reference: 35717657 2025/005/026/601/034
MHRA reference: 35717657 2025/005/026/601/034 - Reply form
BihlerMed, LLC: BihlerMed Dual Tip Surgical Light
4 June 2025
Operating room light
Model: 2762-01-0003, 2762-01-0004
MHRA reference: 35886583 2025/005/009/601/042
MHRA reference: 35886583 2025/005/009/601/042 – Updated FSN
Change Healthcare: Change Healthcare Cardiology
June 2025
Cardiology information system
Model: 15.1.1
MHRA reference: 35918363 2025/006/018/601/106
GE Medical Systems Ultrasound and Primary Care Diagnostics: Venue Go, Venue Fit
FMI 78101
Ultrasound system, imaging, general-purpose
MHRA reference: 35877825 2025/004/008/601/113
Johnson ; Johnson Vision Care: ACUVUE OASYS MAX 1-Day MULTIFOCAL
10 June 2025
Soft corrective contact lens, daily-disposable
MHRA reference: 35922445 2025/006/005/601/025
Medtronic: CareLink SmartSync common application
June 2025
MHRA reference: 35932519 2025/006/019/601/033
MHRA reference: 35932519 2025/006/019/601/033 - Customer Acknowledgement Form
MicroAire Surgical Instruments LLC: SmartRelease ESTR
6 May 2025
Endoscopic soft tissue release blade
Model: Not Applicable
MHRA reference: 35930178 2025/006/019/601/095
Philips Medical Systems Nederland BV: Philips Azurion 7 M20
3 June 2025
Angiographic X-ray System
Model: 722079
MHRA reference: 35910309 2025/006/004/601/070
Randox Laboratories Ltd: UREA
28 April 2025
MHRA reference: 35826367 2025/004/029/601/038
Regal Prosthesis Ltd: POLYCENTRIC 4 BAR MANUAL LOCKING KNEE
12 June 2025
Model: 2-01-S400L
MHRA reference: 35930095 2025/006/019/601/019
Serosep Limited: EntericBio GastroPanel 2 v3
18 June 2025
Multiple gastrointestinal pathogen nucleic acid
MHRA reference: 35918388 2025/006/011/601/028
Vascutek Ltd: Gelsoft Plus (MDR), Gelweave (MDR)
6 June 2025
Synthetic vascular prostheses
Model: All Gelsoft Plus MDR configuration (except 636006PE), Gelweave Thoracoabdominal, Gelweave Y Arch, Gelweave Ante-Flo XL Offset, Gelweave Ante-Flo, Gelweave Straight
MHRA reference: 35886350 2025/006/013/601/042
WEINMANN Emergency Medical Technology GmbH + Co.KG : MEDUMAT Standard², with and without CO2
May 2025
MEDUMAT Standard²
Model: 28710-01, 28710-02,28710-03, 28710-04,15983,28980,15946
MHRA reference: 35885629 2025/006/015/601/001