Field Safety Notices: 3 to 7 August 2026
List of Field Safety Notices from 3 to 7 August 2026.
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
BioFire Diagnostics: FILMARRAY TORCH Base
10 August 2026
Thermal cycler nucleic acid amplification analyzer
Model: Shipping Configuration: HTFA-ASY-0001; Part Number: HTFA-ASY-0104
MHRA reference: 40414156 2026/008/003/601/147
Fritz Stephan: EVE
June 2026
Neonatal/adult intensive-care ventilator
Model: EVE-IN, EVE-IN with Masimo, EVE-NEO, EVE-TR, and EVE-TR with Masimo
MHRA reference: 40414858 2026/008/003/601/060
Given Imaging: Bravo CF capsule delivery
August 2026
Gastrointestinal telemetric monitoring system
Model: FGS-0635, FGS-0636
MHRA reference: 40458808 2026/008/003/601/045
ICU Medical: IV Sets or Administration Sets
14 August 2026
Intravenous administration tubing extension set
MHRA reference: 40445205 2026/008/005/601/030
Intervascular: CARDIOROOT Woven
04 August 026
Graft, vascular, synthetic
Model: HEWROOT0024; HEWROOT0026; HEWROOT0028;HEWROOT0030; HEWROOT0032 ; HEWROOT0034
MHRA reference: 40441248 2026/008/005/601/110
Leonhard Lang: Skintact
30 July 2026
Skintact defibrillation electrodes
Model: 50116 DF28N ZOLL
MHRA reference: 40446622 2026/007/027/601/076
Medbar: Endoscopy Mouthpiece
03 August 2026
MHRA reference: 40441795 2026/005/014/601/011
medin Medical Innovation: medin-NC3
20 July 2026
Neonatal CPAP unit
Model: NC3
MHRA reference: 40430427 2026/008/004/601/014
Nova Biomedical: StatStrip (Gen 2) Glucose and Glucose/ß-Ketone Hosp
July 2026
MHRA reference: 40402698 2026/007/031/601/067
Oscor: Introducer Kit for Impella distributed within the Abiomed Impella 14 Fr and 23 Fr Introducer Kits
30 June 2026
Introducer Kit for Impella
Model: 0052-3006, 0052-3021
MHRA reference: 40456893 2026/007/002/601/071
Philips: Patient Information Center iX, PIC iX Essentials
31 July 2026
Model: 866389, 867093
MHRA reference: 40414903 2026/008/004/601/022
Rocialle Healthcare: Bandage Ortho Wool (Velband) 10cm
05 August 2026
Model: RML111-301
MHRA reference: 40458896 2026/008/006/601/042