Field Safety Notices: 16 to 20 June 2025
Source: gov.uk (2025-06-24)

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 the latest FSNs (https://mhra-gov.filecamp.com/s/o/BcRy1IFOEFpLJt24)

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)

Abbott Ireland Diagnostics Division: Alinity i Total PSA Reagent Kit

22 May 2025

MHRA reference: 35717657 (https://mhra-gov.filecamp.com/s/d/y5MLZPRMI8rsIGAI) 2025/005/xx-xxxx-xxxx

MHRA reference: 35717657 (https://mhra-gov.filecamp.com/s/d/RU5R1JFCLlXTTDiz) 2025/005/xx-xxxx-xxxx - Reply form

BihlerMed, LLC: BihlerMed Dual Tip Surgical Light

4 June 2025

Operating room light

Model: xx-xxxx-xxxx, xx-xxxx-xxxx

MHRA reference: 35886583 (https://mhra-gov.filecamp.com/s/d/b2o0DEWzvfPcKNkk) 2025/005/009/601/042

MHRA reference: 35886583 (https://mhra-gov.filecamp.com/s/d/vZ1zdzTMAVeENiSn) 2025/005/009/601/042 – Updated FSN

Change Healthcare: Change Healthcare Cardiology

June 2025

Cardiology information system

Model: 15.1.1

MHRA reference: 35918363 (https://mhra-gov.filecamp.com/s/d/42uTfh63SLhhdrmW) 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 (https://mhra-gov.filecamp.com/s/d/vPhrdj6UBqLHIkU4) 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 (https://mhra-gov.filecamp.com/s/d/KDOBbrXhsBN6bYgH) 2025/006/005/601/025

Medtronic: CareLink SmartSync common application

June 2025

MHRA reference: 35932519 (https://mhra-gov.filecamp.com/s/d/fTCmiVXiMKxqW5IQ) 2025/006/019/601/033

MHRA reference: 35932519 (https://mhra-gov.filecamp.com/s/d/1sHgd32ylnoDlBJ8) 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 (https://mhra-gov.filecamp.com/s/d/ym2FjmgIb08YH6b2) 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 (https://mhra-gov.filecamp.com/s/d/AuEy725vSAaPXEIp) 2025/006/004/601/070

Randox Laboratories Ltd: UREA

28 April 2025

MHRA reference: 35826367 (https://mhra-gov.filecamp.com/s/d/oQmaRYxzCUe1nG4R) 2025/004/xx-xxxx-xxxx

Regal Prosthesis Ltd: POLYCENTRIC 4 BAR MANUAL LOCKING KNEE

12 June 2025

Model: 2-01-S400L

MHRA reference: 35930095 (https://mhra-gov.filecamp.com/s/d/924gAGU4qFRB7tSK) 2025/006/019/601/019

Serosep Limited: EntericBio GastroPanel 2 v3

18 June 2025

Multiple gastrointestinal pathogen nucleic acid

MHRA reference: 35918388 (https://mhra-gov.filecamp.com/s/d/wHbjDjwJubahBNOF) 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 (https://mhra-gov.filecamp.com/s/d/b9s0wWuCUhtu0FW2) 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 (https://mhra-gov.filecamp.com/s/d/ve7D8xHyrlDiTTBX) 2025/006/015/601/001