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 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