MHRA Field Safety Notices for Medical Devices (March 16-20, 2026)
Summary
The MHRA has published a list of seven Field Safety Notices (FSNs) related to medical devices issued between March 16 and March 20, 2026. These notices are published 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 published a compilation of seven Field Safety Notices (FSNs) concerning medical devices. These FSNs were issued between March 16 and March 20, 2026, and cover a range of devices including diagnostic kits, surgical systems, and monitoring equipment. Specific FSNs include those for AusDiagnostics Respiratory Pathogens, Clinical Innovations Kiwi Omni Vacuum Delivery System, Diagnostic Grifols Serascan Diana 3, Elekta Leksell Vantage Arc System, GE Medical Systems SIGNA Premier, Immucor Panocell-20, and Medtronic Sphere-9 catheter.
These notices are published by the MHRA for informational purposes only. Healthcare providers and medical device manufacturers receiving an FSN are instructed to always act upon it. For specific questions regarding an FSN, individuals should contact the respective manufacturer directly. No immediate compliance actions are mandated by this publication itself, beyond the existing obligation to respond to individual FSNs as they are received.
What to do next
- Act on any Field Safety Notice received from a manufacturer.
- Contact the manufacturer for questions regarding a specific FSN.
Source document (simplified)
Field Safety Notices: 16 - 20 March 2026
List of Field Safety Notices for 16 - 20 March 2026
From: Medicines and Healthcare products Regulatory Agency Published 24 March 2026 Message type: Field safety notice Issued: 24 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
AusDiagnostics: Respiratory Pathogens 24 well
19 March 2026
MHRA reference: 38871547 2026/003/013/601/005
Clinical Innovations: Kiwi Omni Vacuum Delivery System
11 March 2026
Foetal vacuum extraction system cup, single-use
Model: VAC-6000MTE
MHRA reference: 38815266 2026/003/011/601/122
Diagnostic Grifols: Serascan Diana 3
11 March 2026
MHRA reference: 38819756 2026/003/013/601/018
Elekta: Leksell Vantage Arc System
February 2026
Stereotactic surgery system, neurological
MHRA reference: 38774245 2026/003/010/601/069
GE Medical Systems: SIGNA Premier
Ref 63006
MHRA reference: 38868186 2026/003/018/601/010
Immucor: Panocell-20
15 January 2026
Model: IMM0005020
MHRA reference: 38879726 2026/003/019/601/160
Medtronic: Sphere-9 catheter
March 2026 FA1546
Model: AFR-00001
MHRA reference: 38871827 2026/003/006/601/106
PathoFinder: RealAccurate® Quadruplex Bordetella PCR Kit
17 March 2026
MHRA reference: 38879290 2026/003/019/601/065
Spacelabs: Xprezzon Bedside Monitor
Ref 3010157426-08112025-001-C
Single-patient physiologic monitoring system
Model: 91393
MHRA reference: 38869445 2026/002/019/601/054
Stryker: Darco 7.0 Headless Screw 16x6
March 2026
MHRA reference: 38886954 2026/002/027/601/077
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Published 24 March 2026 Contents
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