Medicines Healthcare Products Regulatory Agency
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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
Allurion: Allurion Device / Elipse Gastric Balloon System
22 January 2025
Balloon, gastric, appetite-suppressing
Model: 10D
MHRA reference: 34605771 2025/001/031/601/011
Baxter : EXTENDED LIFE PD TRANSFER SET, MINICAP EXTEND LIFE
23 October 2024
Tubing set, peritoneal dialysis
MHRA reference: 34640703 2024/010/022/601/043 - Letter
Baxter: AK 95, AK 96, AK 98
28 January 2025
Haemodialysis system Institutional / Home-Use
Model: 107012, 107119, 110656, 114742, 115250, 955404, 955604
MHRA reference: 34599078 2025/001/028/601/056
MHRA reference: 34599078 2025/001/028/601/056 - Home Patient Letter
MHRA reference: 34599078 2025/001/028/601/056 Attachment 1
BRAINLAB: Multidisciplinary medical image management SW
CAPA-20250117-002791
Origin Data Management
Model: 30074-04B, 30074-04C
MHRA reference: 34641428 2025/002/005/601/017
Dexcom: Dexcom G6 Receiver
January/February 2025
Percutaneous glucose monitoring system
Model: MT24078-1 (mg/dL), MT24078-2 (mmol/L)
MHRA reference: 34652451 2025/001/009/601/082
Drager: Ventstar Flex breathing circuits
February 2025
MHRA reference: 34630476 2025/002/004/601/068
Gama Healthcare: Clinell Contiplan
23 January 2025
MHRA reference: 34613318 2025/001/023/601/049
Hamilton Medical: In2Flow Nasal cannula (sizes S, M, L)
6 February 2025
Nasal oxygen cannula, basic
Model: 10076606, 10076605, 10076604
MHRA reference: 34649940 2025/002/006/601/042
MHRA reference: 34649940 2025/002/006/601/042
Hologic: Panther Fusion Tube Trays
30 January 2025
Model: FAB-15004
MHRA reference: 34601187 2025/001/031/601/061
KLS Martin: OR light system (marLED E marLED X)
9 December 2024
Op./ex./treatm light mount,fix
MHRA reference: 34603880 2024/012/010/601/022
Medtronic: 37307: Activa SC 48054: Pocket Adaptor
January 2025
MHRA reference: 34613389 2024/005/014/601/019
Steris: Cataract Set and Zeiss Microscope Caps
24 January 2025
MHRA reference: 34606148 2024/012/031/601/075