MHRA Field Safety Notices for Medical Devices
Summary
The MHRA has published a list of Field Safety Notices (FSNs) for medical devices issued between March 9-13, 2026. These notices are for informational purposes, and recipients are advised to act on any FSN received from a manufacturer.
What changed
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a notice listing Field Safety Notices (FSNs) for various medical devices that were published between March 9 and March 13, 2026. The listed FSNs pertain to products from manufacturers including Armstrong Medical, Gyrus, ICU Medical, Medical (Physio-Control Inc), Milestone, and Trividia Health, with specific MHRA references and product details provided for each.
Regulated entities, particularly healthcare providers and medical device manufacturers, are reminded that they must always act upon receiving a Field Safety Notice. The MHRA publishes these notices for informational purposes only. For specific questions regarding an FSN, the manufacturer of the device should be contacted directly. No immediate compliance actions are mandated by this notice itself, as it serves as an informational update.
What to do next
- Review the listed Field Safety Notices for any applicable devices.
- Contact the respective manufacturers for clarification or action if a relevant FSN is identified.
Source document (simplified)
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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