Field Safety Notices: 5 to 9 May 2025
Source: gov.uk (2025-08-21)

List of Field Safety Notices from 5 to 9 May 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 the latest FSNs (https://mhra-gov.filecamp.com/s/o/FyLLz7PV8BHqxzVX)

View a list of FSNs published since January 2020 (https://mhra-gov.filecamp.com/s/9g5cLjjFatXruS5U/d)

View FSNs since November 2014 (https://mhra-gov.filecamp.com/s/ZOxdOzRzP22RziUW/fo). FSNs before this date are on the National Archives website (https://webarchive.nationalarchives.gov.uk/*/http:/www.mhra.gov.uk/index.htm)

Alcon Laboratories : Ophthalmic surgical procedure kit, non-medicated

8 May 2025

Constellation Total Plus Pak

Model: See Attached

MHRA reference: 35526985 (https://mhra-gov.filecamp.com/s/d/rfjWcyITWBUXYKMz) 2025/005/008/601/101

Avanos Medical Inc : Introducer Kit for Gastrostomy Feeding Tube

6 May 2025

Gastrostomy procedure kit

Model: 98430; 98431; 98432; 98433; 98434

MHRA reference: 35504411 (https://mhra-gov.filecamp.com/s/d/02GEwSISkZg49Fr3) 2025/005/006/601/137

Beckman Coulter : Sample Probe

2 May 2025

See Section 8

MHRA reference: 35526963 (https://mhra-gov.filecamp.com/s/d/640LH5e2EvvTkHXm) 2025/005/008/601/117

MHRA reference: 35526963 (https://mhra-gov.filecamp.com/s/d/CbPEdLrOaX9V7GH6) 2025/005/008/601/117 – Vigilance response form

MHRA reference: 35526963 (https://mhra-gov.filecamp.com/s/d/vRtJIbXcK1UfUQyx) 2025/005/008/601/117 – Vigilance response form

Beckman Coulter Inc : Apolipoprotein B (Apo B)

1 May 2025

See Section 8

MHRA reference: 35517370 (https://mhra-gov.filecamp.com/s/d/dkmgEq9eS4ctF1AX) 2025/005/007/601/117 – Vigilance response form

MHRA reference: 35517370 (https://mhra-gov.filecamp.com/s/d/2eAEyiFRwFtL0UD8) 2025/005/007/601/117 – Customer letter

Beckman Coulter: DxI 9000 Access Immunoassay Analyzer

1 May 2025

See section 8

MHRA reference: 35504362 (https://mhra-gov.filecamp.com/s/d/JT7lJCp46EqxKUqQ) 2025/005/006/601/088

Beckman Coulter: DxI 9000 Access Immunoassay Analyzer

1 May 2025

See section 8

MHRA reference: 35518231 (https://mhra-gov.filecamp.com/s/d/51FGSnfh6jPgtlsz) 2025/005/007/601/088 - Vigilance Response Form

MHRA reference: 35518231 (https://mhra-gov.filecamp.com/s/d/rQVd6F43MLB0NDYX) 2025/005/007/601/088 - Customer Letter UK

BioMérieux SA: VIDAS® TOXO Compétition

11 May 2025

Toxoplasma gondii total antibody IVD, kit, enzyme

MHRA reference: 35504284 (https://mhra-gov.filecamp.com/s/d/ksCFPDWZhQ0kI4Y2) 2025/005/006/601/069

Covidien llc: Hugo™ RAS Tower (120VAC), Hugo™ RAS Tower (240VAC)

April 2025

ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS

MHRA reference: 35442350 (https://mhra-gov.filecamp.com/s/d/QDDkIttBSSlEGPxx) 2025/004/xx-xxxx-xxxx

ICU Medical Inc: CADD-Solis™ Ambulatory Infusion Pumps

9 May 2025

Bedside infusion pump, single-channel

Model: See FSN

MHRA reference: 35503251 (https://mhra-gov.filecamp.com/s/d/E2ox8TXjGPWL0sIH) 2025/005/006/601/043 - Letter

MHRA reference: 35503251 (https://mhra-gov.filecamp.com/s/d/nSXCXIq5KOV3NwXt) 2025/005/006/601/043

ICU Medical Inc : CADD-Solis™ Ambulatory Infusion Pumps

9 May 2025

Bedside infusion pump, single-channel

Model: See FSN

MHRA reference: 35504833 (https://mhra-gov.filecamp.com/s/d/N9C6uIej982a8T00) 2025/005/006/601/044

ICU Medical Inc: CADD-Solis™ Ambulatory Infusion Pumps

9 May 2025

Bedside infusion pump, single-channel

Model: See FSN

MHRA reference: 35503450 (https://mhra-gov.filecamp.com/s/d/mR7xespdY2iQ5Po5) 2025/005/006/601/042 - Letter

MHRA reference: 35503450 (https://mhra-gov.filecamp.com/s/d/rZW9YEcfjJkpJmSs) 2025/005/006/601/042

Medical Innovation Developpment : MID-TUBE

27 March 2025

MHRA reference: 35503992 (https://mhra-gov.filecamp.com/s/d/0FQpB34d9HhLuhzu) 2025/005/007/601/009

Medtronic MINIMED : Simplera™ sensors

May 2025

MHRA reference: 35517712 (https://mhra-gov.filecamp.com/s/d/Dyzg8VsmDCS6KH6M) 2025/005/007/601/023

MHRA reference: 35517712 (https://mhra-gov.filecamp.com/s/d/8inD5IgiIhxdYIWc) 2025/005/007/601/023 – HCP letter

MHRA reference: 35517712 (https://mhra-gov.filecamp.com/s/d/K3H8cdj1VgxVVWCh) 2025/005/007/601/023 – HCP courtesy letter

Medtronic Navigation Inc: StealthStationTM Cranial and SynergyTM Cranial

December 2023

Neurological stereotactic surgery system

Model: 9735585, 9735586, 9735587

MHRA reference: 35518550 (https://mhra-gov.filecamp.com/s/d/slroTOAmXlozYn90)

MHRA reference: 35518550 (https://mhra-gov.filecamp.com/s/d/VW86KCRNVZWi5Ume) - Customer Acknowledgement Form

Natus Medical Incorporated DBA Excel-Tech Ltd : Olympic Brainz Monitor (Digital Acquisition Box)

FCA#000057

Model: OBM00002

MHRA reference: 35495461 (https://mhra-gov.filecamp.com/s/d/kLtlyvLS95VB8m3k) 2025/005/002/601/075 - Customer letter

Schiller Medical: SCHILLER

April 2025

Monitoring system

Model: MAGLIFE RT-1

MHRA reference: 36497451 (https://mhra-gov.filecamp.com/s/d/pKOtngBt5J5tL3nf) 2025/004/xx-xxxx-xxxx

SkylineDx BV: Merlin Assay (incl. software MAAS)

28 April 2025

MHRA reference: 35517900 (https://mhra-gov.filecamp.com/s/d/tl8uLmrBTjn6CYlk) 2025/005/006/601/132