Field Safety Notices: 27 to 31 October 2025
List of Field Safety Notices from 27 to 31 October 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
Beckman Coulter: UniCel DxI 600 and 800 Analyzers
1 October 2025
MHRA reference: 37457734 2025/010/001/601/015
Breas Medical: Clearway 2
28 October 2025
In-exsufflator
Model: 232000
MHRA reference: 37484961
Delcath Systems: CHEMOSAT
13 October 2025
Hemoperfusion Unit
MHRA reference: 37478494 2025/010/009/601/040
Dieter Marquardt: VITUS-Fi Distal Fibula Nail
6 October 2025
nail, bone
MHRA reference: 37459667 2025/010/023/601/081
Egton Medical Information Systems Ltd trading as Optum: ePMA
29 October 2025
Pharmaceutical Reference Data Software
MHRA reference: 37508274 2025/010/029/601/145
Immucor: PakPlus
March 2025 FA-WKS-25-003
MHRA reference: 37496060 2025/010/029/601/122
Immucor: Factor VIII Antibody Screen
March 2025 FA-WKS-25-004
Coagulation factor VIII IVD, kit, chromogenic
Model: F8S
MHRA reference: 37501132 2025/010/029/601/134
Inpeco: FlexLab X
28 October 2025
MHRA reference: 37507678 2025/010/030/601/056
Medtrade: CELOX PPH
20 October 2025
Model: FG08838281, FG08838171, FG08838291 and FG08838321
MHRA reference: 37498213 2025/010/028/601/074
Rocialle Healthcare: Specimen Container 30ml double wrapped
7 August 2025
MHRA reference: 37458768 2025/010/004/601/002
Siemens: Atellica CI Analyzer, Atellica IM Analyzer, ADVIA Centaur XP System, ADVIA Centaur XPT System, ADVIA Centaur CP System
October 2025
MHRA reference: 37478314 2025/004/015/601/086