Field Safety Notices: 20 to 24 October 2025
Source: gov.uk (2025-10-28)

List of Field Safety Notices from 20 to 24 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 the latest FSNs (https://mhra-gov.filecamp.com/s/o/pVUeJq2k8gD5NtK0)

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)

Baxter Healthcare SA: EVO IQ Large Volume Pump

15 August 2025

Bedside infusion pump, single-channel

Model: ELVP001UKI

MHRA reference: 37397515 (https://mhra-gov.filecamp.com/s/d/0x8s3nQnmlRgtBxF) 2024/011/xx-xxxx-xxxx

MHRA reference: 37397515 (https://mhra-gov.filecamp.com/s/d/Yno3MknlfRYvdnLq) 2024/011/xx-xxxx-xxxx – Customer reply form

Bio-Rad: Genie Fast HIV ½

9 October 2025

HIV1/HIV2 antibody IVD, kit, (ICT), rapid

MHRA reference: 37398742 (https://mhra-gov.filecamp.com/s/d/kR8IfPbDwmpmcJoR)

Cardinal Health 200, LLC: Kendall SCD™ 700 Sequential Compression System

22 October 2025

Pneumatic Compression Equipment

MHRA reference: 37418709 (https://mhra-gov.filecamp.com/uniq/3p24UpcG7vCdwy1Q.pdf) 2025/010/xx-xxxx-xxxx

Cepheid AB : Xpert HIV-1 Viral Load XC

13 October 2025

MHRA reference: 37419965 (https://mhra-gov.filecamp.com/s/d/BTHhuI8oK77DmT7t) 2025/010/xx-xxxx-xxxx

Cepheid AB : Xpert CT/NG

20 October 2025

MHRA reference: 37436381 (https://mhra-gov.filecamp.com/s/d/WB9QZPth32n0Bnur) 2025/010/010/601/056

Datex-Ohmeda, Inc: Giraffe Omnibed Carestation CS1; Giraffe Omnibed

21 March 2025

Incubator, infant, stationary

MHRA reference: 37420686 (https://mhra-gov.filecamp.com/s/d/7NpV9e7cuGtw85lz) 2024/010/011/601/027

MHRA reference: 37438630 (https://mhra-gov.filecamp.com/s/d/CtxkVSnEYsqGDmQU) 2024/010/011/601/027

(Both FSNs are different and each FSN requires attention.)

GE Ultrasound Korea, Ltd: LOGIQ P9 and P10

FMI 74084

Ultrasound System Imaging, General Purpose

MHRA reference: 37444100 (https://mhra-gov.filecamp.com/s/d/leybgv7GleCVyhxk)

HUMAN Gesellschaft für Biochemica und Diagnostica mbH: AUTOCAL

16 October 2025

Multiple-type clinical chemistry analyte profile I

MHRA reference: 37398566 (https://mhra-gov.filecamp.com/s/d/lIUCZDOvt3VNtMus)

MHRA reference: 37398566 (https://mhra-gov.filecamp.com/s/d/TEktNwjG5iLvoALO) – reply form

KANEKA Corporation: Senri ™ balloon dilatation catheter

9 October 2025

MHRA reference: 37397044 (https://mhra-gov.filecamp.com/s/d/QAI5Joof1gw2A4rS) 2025/010/006/601/017

Medical (Heartsine Technologies Ltd.): HeartSine samaritan Pad-Pak and Pediatric-Pak

6 October 2025

MHRA reference: 37396940 (https://mhra-gov.filecamp.com/s/d/QWEBCHQPWLQIXsse) 2025/009/xx-xxxx-xxxx

Remote Diagnostic Technologies Ltd : Tempus Pro

9 October 2025

Transportable physiologic monitoring system

Model: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R

MHRA reference: 37411962 (https://mhra-gov.filecamp.com/s/d/D55Ywa9pZoQ7LiLx) 2025/004/017/601/037

SCHILLER AG : EASY PULSE

17 October 2025

Cardiac resuscitator, battery-powered

Model: 3.940409 (GTIN: xx-xxxx-xxxx.940410 (GTIN: xx-xxxx-xxxx)

MHRA reference: 37400930 (https://mhra-gov.filecamp.com/s/d/Y8xquMmSXxITyZP9)

Shenzhen Mindray bio-medical electronics, ltd: V90 electronic vaporizer

13 October 2025

MHRA reference: 37398834 (https://mhra-gov.filecamp.com/s/d/7P3ToKQPOl9EIGUk)

Synthes GmbH, Oberdorf : MatrixMIDFACE & MatrixMANDIBLE

15 October 2025

Craniofacial bone screw, non-bioabsorbable

Model: NA546-31-0000546-31-2000546-31-4000546-31-6000546-31-8000546-32-0000

MHRA reference: 37425126 (https://mhra-gov.filecamp.com/s/d/hZFLiFOjuNXHq2Ud) 2025/010/014/601/087