Field Safety Notices for Medical Devices: 16-20 March 2026
Summary
MHRA published 10 Field Safety Notices for medical devices covering the period 16-20 March 2026, affecting products from manufacturers including AusDiagnostics, Clinical Innovations, Diagnostic Grifols, Elekta, GE Medical Systems, Immucor, Medtronic, PathoFinder, Spacelabs, and Stryker. The FSNs cover diagnostic tests, foetal vacuum extraction systems, stereotactic surgery systems, MRI equipment, blood typing reagents, catheters, physiologic monitors, and orthopaedic devices. MHRA clarifies this is published for information only and advises that recipients must always act on FSNs received directly from manufacturers.
“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 its weekly compilation of Field Safety Notices for medical devices, covering 10 products across diagnostic equipment, therapeutic devices, and monitoring systems from nine manufacturers. The FSNs span products including respiratory pathogen tests, foetal delivery systems, neurological surgery equipment, MRI scanners, blood typing reagents, cardiac ablation catheters, bedside monitors, and orthopaedic screws. MHRA explicitly states this publication is for information only and that recipients of FSNs directly from manufacturers must act on them — the compilation itself does not create new obligations but consolidates existing manufacturer-issued safety communications.
Healthcare providers and medical device users should monitor the linked FSNs from manufacturers for specific actions required, as each FSN may contain device-specific corrective measures. Facilities with affected device categories should verify whether they hold any of the listed products and follow manufacturer instructions. The MHRA reference numbers provided can be used to access full FSN details directly from the agency or manufacturer.
Archived snapshot
Mar 24, 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: 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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