Field Safety Notices: 9-13 March 2026
Summary
MHRA published six Field Safety Notices (FSNs) for medical devices covering the period 9-13 March 2026. Notices cover devices from Armstrong Medical (APL Valve), Gyrus (Soltive Laser System), ICU Medical (CADD High Volume Administration Sets), Physio-Control Inc (Infant/Child Reduced Energy Defibrillation Electrode), Milestone (Vacuum Bag Su Large), and Trividia Health (TRUE METRIX glucose monitoring systems). The page is published for information only — FSNs must be obtained directly from the manufacturers via the provided links.
“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 compiled and published six Field Safety Notices (FSNs) for medical devices covering the period 9-13 March 2026. The FSNs relate to devices including the Armstrong Medical APL Valve, Gyrus Soltive Laser System, ICU Medical CADD Administration Sets, Physio-Control Infant/Child Defibrillation Electrode, Milestone Vacuum Bag, and Trividia Health TRUE METRIX glucose monitoring systems. Each FSN carries an MHRA reference number and links to manufacturer-issued safety documentation.\n\nHealthcare providers and medical device users should note that MHRA explicitly states FSNs are published for information only and direct queries to the relevant manufacturer. While the page itself does not impose new regulatory obligations, the underlying FSNs require appropriate action by affected parties — MHRA advises that recipients must always act on manufacturer-issued Field Safety Notices.
Archived snapshot
Mar 17, 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: 9 - 13 March 2026
A list of Field Safety Notice for 9 - 13 March 2026
From: Medicines and Healthcare products Regulatory Agency Published 17 March 2026 Message type: Field safety notice Issued: 17 March 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
Armstrong Medical: APL Valve
09 March 2026
MHRA reference: 38762128 2026/003/006/601/108
Gyrus: Soltive Laser System
16 March 2026
General/multiple surgical solidstate laser system
Model: TFL-PLS, TFL-SLS
MHRA reference: 38782537
ICU Medical: CADD High Volume Administration Sets
13 February 2026
Electric infusion pump administration set
Model: 21-7361-24
MHRA reference: 38755259 2026/002/010/601/028
Medical (Physio-Control Inc): INFANTCHILD REDUCED ENERGY DEFFIBRILATION ELECTROD
February 2026
ELECTASSY-AED INFANTCHILD REDUCED ENERGY-WW
MHRA reference: 38761418 2026/003/009/601/115
Milestone: VACUUM BAG SU LARGE
09 March 2026
General tissue specimen container IVD, no additive
MHRA reference: 38761720 2026/003/009/601/096
Trividia Health: TRUE METRIX, TRUE METRIX AIR, TRUE METRIX GO
12 February 2026
Glucose monitoring system IVD, home-use
Model: RE4i82-11; RE4i82-12; REA4i82-11; REA4i82-12; RF4i82-11BK; RF4i82-12BK
MHRA reference: 38559200 2026/002/011/601/061
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Published 17 March 2026 Contents
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