Field Safety Notices: 25 to 29 August 2025
Source: gov.uk (2025-09-03)

List of Field Safety Notices from 25 to 29 August 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/cdJ1k2rwCnVg1IvZ)

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)

CareDx Pty Ltd: AlloSeq cfDNA

21 August 2025

Model: Refer to FSN

MHRA reference: 36545854 (https://mhra-gov.filecamp.com/s/d/qVS6qdepLHODtz2i) 2025/008/xx-xxxx-xxxx

Datascope Corp-Getinge: CARDIOSAVE IABP HYBRID AND RESCUE CONFIGURATIONS OT 577031 - FLUID INGRESS

20 August 2025

Cardiosave Intra-Aortic Balloon Pumps

Model: Refer to FSN

MHRA reference: 36545743 (https://mhra-gov.filecamp.com/s/d/qdKEGUVlG1tKa86M) 2025/008/xx-xxxx-xxxx

Fiab SpA: Defibrillation electrodes model F7987W

20 August 2025

FSN ref: 187

Disposable adhesive electrodes for external defibrillation

Model/LOT: Refer to FSN

MHRA reference: 36565517 (https://mhra-gov.filecamp.com/s/d/U9Mej78N1aMivhK5) 2025/008/xx-xxxx-xxxx

GE HealthCare: Optima XR200amx, Optima XR220amx and Optima XR240amx – UPDATED FSN

28 July 2025

Ref. # 10964-C

Update to FSN ref MHRA reference: 34176852 (https://mhra-gov.filecamp.com/s/d/y5JfASuPn41Pigls)

X-ray system, diagnostic, General-Purpose, Mobile

MHRA reference: 36571165 (https://mhra-gov.filecamp.com/s/d/houLYth4XSXxVOOr) 2024/012/010/601/088

Gyrus ACMI, Inc / Olympus: ViziShot 2 FLEX (19G)

13 August 2025

Endoscopic ultrasound-guided aspiration needle

Model: Refer to FSN

MHRA reference: 36558600 (https://mhra-gov.filecamp.com/s/d/q5ZbC7eeW0t9LVK8) 2025/008/008/601/010

ICU Medical: CADD Medication Cassette Reservoir

28 August 2025

Infusion pump cassette

Model: Refer to FSN

MHRA reference: 36547888 (https://mhra-gov.filecamp.com/s/d/PJiPZ79R5V47ZzGE) 2025/008/xx-xxxx-xxxx

IntersurgicaL Ltd: Various BVM Resuscitators

28 August 2025

BVM Resuscitators

Model: Refer to FSN

MHRA reference: 35876831 (https://mhra-gov.filecamp.com/s/d/LB5z0jwnzeaHPvUi) 2025/005/019/601/023

Jaeger Medical: VYNTUS products with SNIP/RHINO Option

18 August 2025

CRF#: 2020-036

Reprocessing instructions

Model: Refer to FSN

MHRA reference: 36524861 (https://mhra-gov.filecamp.com/s/d/dXajYyM4n9Fonv8l)

Riverside Medical Packaging: Aseptic Medical Devices (AMD) Sterile Transfer Sets & Accessories

20 August 2025

FSN 2025-001

Model: Refer to FSN

MHRA reference: 36548829 (https://mhra-gov.filecamp.com/s/d/VIAA1WoZhfeoWux8) 2025/008/xx-xxxx-xxxx

Siemens Healthcare: INNOVANCE VWF Ac

June 2025

Model: Refer to FSN

MHRA reference: 36497358 (https://mhra-gov.filecamp.com/s/d/0EnIOKEiNtlmC5mF) 2025/007/004/601/047

Stryker: STRYKEFLOW2

August 2025

Recall Number: RA2025- 4025396

STRYKEFLOW2 WITH /without DISPOSABLE TIP

Model: Refer to FSN

MHRA reference: 36546104 (https://mhra-gov.filecamp.com/s/d/FS3oQGmPU9u8ejVY) 2025/008/xx-xxxx-xxxx