Field Safety Notices: 6 to 10 April 2026
List of Field Safety Notices for 6 to 10 April 2026.
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 . FSNs before this date are on the
Allurion: Allurion Gastric Balloon System
27 March 2026
Balloon, gastric, appetite-suppressing
Model: 10D
MHRA reference: 2026/004/002/601/160
Bonree Medical: GenCath Open Suction Catheter
April 2026
MHRA reference: 2026/004/009/601/041
Boston Scientific: POLARx & POLARx FIT, POLARSHEATH, SMARTFREEZE
09 April 2026
MHRA reference: 2026/004/007/601/051
BVI Liège/ PhysIOL: PODEYE
09 April 2026
Intraocular Lens posterior chamber pseudophakic
Model: PODAGF+21.5, PODAGF+23.0, PODAGF+24.0
MHRA reference: 2026/004/003/601/045
Edwards Lifesciences: EVOQUE Tricuspid Delivery System
31 March 2026
Tricuspid transcatheter heart valve bioprosthesis
Model: 9850TDS
MHRA reference: 2026/003/026/601/112
GE HealthCare: Revolution Ascend
Ref 23015
Full-body CT system
MHRA reference: 2026/004/007/601/073
Intuitive Surgical: da Vinci X & Xi Surgical System
Ref ISIFA2026-01-C
Robotic Surgical System
Model: IS4000 Surgical System; IS4200 Surgical System
MHRA reference: 2026/004/008/601/069
Medline: Angiographic Control Syringe with Rotating Adaptor
09 April 2026 FSN-26-04
MHRA reference: 2026/004/009/601/055
Medline: Angiographic Control Syringe with Rotating Adaptor
09 April 2026 FSN-26-03
MHRA reference: 2026/004/009/601/047
Medline: Angiographic Control Syringe with Rotating Adaptor
Ref FSN-26-03
MHRA reference: 2026/004/009/601/047
MEQU: M Warmer
31 March 2026
Model: MWS201
MHRA reference: 2026/004/002/601/108
Merivaara: Q-Flow surgical lights
31 March 2026
Operating room light system
Model: Q-FLOW SOLO, Q-FLOW DUO, Q-FLOW TRIO, Q-FLOW QUAD, Q-FLOW MOBILE
MHRA reference: 2026/004/002/601/114
Rand: ILP HT
02 April 2026
Intravascular/intracavitary-circulation hyperthermia system set
MHRA reference: 2026/003/027/601/012
Remel: OXOID Agglutinating Sera, Salmonella 9-0
19 March 2026
MHRA reference: 2026/003/023/601/077
Renishaw Mayfield: neuromate stereotactic surgery system - Headholder
08 April 2026
MHRA reference: 2026/003/025/601/050