Field Safety Notices: 25 to 29 August 2025

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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website

CareDx Pty Ltd: AlloSeq cfDNA

21 August 2025

Model: Refer to FSN

MHRA reference: 36545854   2025/008/021/601/070

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   2025/008/022/601/115

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   2025/008/027/601/020

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

28 July 2025

Ref. # 10964-C

Update to FSN ref MHRA reference: 34176852  

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

MHRA reference: 36571165   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   2025/008/008/601/010

ICU Medical: CADD Medication Cassette Reservoir

28 August 2025

Infusion pump cassette

Model: Refer to FSN

MHRA reference: 36547888   2025/008/025/601/008

IntersurgicaL Ltd: Various BVM Resuscitators

28 August 2025

BVM Resuscitators

Model: Refer to FSN

MHRA reference: 35876831   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   

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

20 August 2025

FSN 2025-001

Model: Refer to FSN

MHRA reference: 36548829   2025/008/022/601/033

Siemens Healthcare: INNOVANCE VWF Ac

June 2025

Model: Refer to FSN

MHRA reference: 36497358   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   2025/008/025/601/037

Updates to this page

Published 3 September 2025