Field Safety Notices: 6 to 10 April 2026
Summary
MHRA published a weekly compilation of 14 Field Safety Notices for the period 6-10 April 2026, covering medical devices from manufacturers including Allurion, Boston Scientific, Edwards Lifesciences, GE HealthCare, Intuitive Surgical, and Medline. Devices include gastric balloon systems, intraocular lenses, tricuspid heart valve delivery systems, CT scanners, robotic surgical systems, and surgical lighting equipment. The agency notes that FSNs are published for information only and advises contacting manufacturers directly with questions.
“If you receive a field safety notice (FSN) from a manufacturer you must always act on it.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
MHRA published a weekly compilation of Field Safety Notices (FSNs) issued by medical device manufacturers for the period 6-10 April 2026. The compilation includes 14 FSNs covering devices such as the Allurion Elipse Gastric Balloon, Boston Scientific POLARx catheter systems, Edwards Lifesciences EVOQUE Tricuspid Valve, GE HealthCare Revolution Ascend CT system, and Intuitive Surgical da Vinci X & Xi robotic systems.\n\nHealthcare providers and medical device users should note that MHRA publishes FSNs for information only and advises recipients to contact manufacturers directly with questions. Facilities should maintain awareness of field safety notices relevant to their device inventory and act on any notices received from manufacturers.
Archived snapshot
Apr 13, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Field Safety Notices: 6 to 10 April 2026
List of Field Safety Notices for 6 to 10 April 2026.
From: Medicines and Healthcare products Regulatory Agency Published 13 April 2026 Message type: Field safety notice Issued: 13 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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Allurion: Elipse Gastric Balloon System
27 March 2026
Balloon, gastric, appetite-suppressing
Model: 10D
MHRA reference: 39095450 2026/004/002/601/160
Bonree Medical: GenCath Open Suction Catheter
April 2026
MHRA reference: 39132092 2026/004/009/601/041
Boston Scientific: POLARx & POLARx FIT, POLARSHEATH, SMARTFREEZE
09 April 2026
MHRA reference: 39107001 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: 39124618 2026/004/003/601/045
Edwards Lifesciences: EVOQUE Tricuspid Delivery System
31 March 2026
Tricuspid transcatheter heart valve bioprosthesis
Model: 9850TDS
MHRA reference: 39063549 2026/003/026/601/112
GE HealthCare: Revolution Ascend
Ref 23015
Full-body CT system
MHRA reference: 39103793 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: 39122168 2026/004/008/601/069
Medline: Angiographic Control Syringe with Rotating Adaptor
09 April 2026 FSN-26-04
MHRA reference: 39131949 2026/004/009/601/055
Medline: Angiographic Control Syringe with Rotating Adaptor
09 April 2026 FSN-26/05
MHRA reference: 39133197 2026/004/009/601/024
Medline: Angiographic Control Syringe with Rotating Adaptor
Ref FSN-26-03
MHRA reference: 39137125 2026/004/009/601/047
MEQU: M Warmer
31 March 2026
Model: MWS201
MHRA reference: 39094898 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: 39092943 2026/004/002/601/114
Rand: ILP HT
02 April 2026
Intravascular/intracavitary-circulation hyperthermia system set
MHRA reference: 38990822 2026/003/027/601/012
Remel: OXOID Agglutinating Sera, Salmonella 9-0
19 March 2026
MHRA reference: 39107701 2026/003/023/601/077
Renishaw Mayfield: neuromate stereotactic surgery system - Headholder
08 April 2026
MHRA reference: 39150197 2026/003/025/601/050
Updates to this page
Published 13 April 2026 Contents
Mentioned entities
Related changes
Get daily alerts for MHRA Guidance & Safety
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from MHRA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when MHRA Guidance & Safety publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.