Field Safety Notices: 15 to 19 September 2025
List of Field Safety Notices from 15 to 19 September 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
Abbott: TactiFlex™ Ablation Catheter, Sensor Enabled™
12 September 2025
Cardiac radio-frequency ablation system catheter
Model: Refer to FSN
MHRA reference: 36769415 2025/009/012/601/033
Baxter Healthcare SA: Sharesource Claria
11 September 2025
FA Number: FAV-2025-007
Nephrology information system software
Product code: 5CGM01
Serial number: software versions 8.13.4
MHRA reference: 36757946 2025/009/009/601/021
Beckman Coulter: DxC 500i Clinical Analyzer
06 August 2025
Model: Refer to FSN
MHRA reference: 36833955 2025/008/004/601/040 FSN
MHRA reference: 36833955 Vigilance response form
Datascope Corp/Getinge: Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP)
August 2025
Circulatory assist system, intra-aortic balloon
Model: Refer to FSN
MHRA reference: 36831024 2025/009/017/601/117
Diagnostic Grifols S.A.: Erytra
10 September 2025
Blood group/antibody screening analyser IVD automa
Product code: 210400 and 210401
Software versions: 4.5.0 and 4.6.0.
MHRA reference: 36770488 2025/009/012/601/078
DiaMed GmbH: ID-Anti-S, Test Serum ID-Anti-M, N, S, s, Fya, Fyb
18 August 2025
Bio-Rad Reference: FSCA-004-25
Anti-S [MNS3] red blood cell grouping IVD
Model: Refer to FSN
MHRA reference: 36834578 2025/008/025/601/014
Epocal Inc/Siemens.: epoc BGEM BUN Test Card [25pk]
July 2025
epoc® Blood Analysis System
Model: Refer to FSN
MHRA reference: 36833855 2025/007/002/601/091
ICU Medical Inc: HOTLINE HL-90 Blood & Fluid Warmer
18 September 2025
Convection blood/fluid warmer
Model: HL-90-UK-230
MHRA reference: 36809273 2025/009/015/601/013
Inogen, Inc.: Inogen Rove 4™ Portable Oxygen Concentrator
September 2025
Ref: FSN-2025-002
Model: Refer to FSN
MHRA reference: 36775210 2025/009/012/601/094
JRI Orthopaedics Ltd: VAIOS Humeral Stem H-AC 10mm Diameter
09 September 2025
Reference: NC592
Coated shoulder humeral stem prosthesis
Model: Refer to FSN
MHRA reference: 36773763 2025/009/001/601/040
Maquet Cardiovascular/Getinge: Heartstring III Proximal Seal System
August 2025
Reference Number: 1336551
Model: Refer to FSN
MHRA reference: 36774157 2025/008/019/601/041
Merit Medical Systems: PhD Hemostasis Valve™
29 July 2025
FSCA Ref: 1721504-07/29/25-007R
Model: Refer to FSN
MHRA reference: 36823137 2025/008/006/601/044
Stryker: Nasopore, Otopore
09 May 2025
RA2025-3888970
Model: Refer to FSN
MHRA reference: 35729161 2025/003/020/601/047
Trinity Biotech: Premier Hb9210 HbA1c Analyzer
16 September 2025
FOLLOW-UP FSN – ref INCDT001-24-3
Update to FSN dated 25 Oct 2024 - MHRA reference: 33769421
Product Code: 42790
Model: Refer to FSN
MHRA reference: 36832689 2024/009/030/601/081
W.L. Gore; Associates: GORE® ACUSEAL Vascular Graft
August 2025
Vascular Graft
Model: Refer to FSN
MHRA reference: 36813123 2025/008/012/601/081