MHRA Medical Device Safety Notices
Summary
The MHRA has issued a list of eight medical device safety notices published between February 9-13, 2026. These notices cover various devices including ventilator circuits, tissue reconstructive material, and PET/CT scanners. The MHRA publishes these for informational purposes.
What changed
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a compilation of eight Field Safety Notices (FSNs) issued between February 9-13, 2026. These notices pertain to a range of medical devices, including ventilator circuits from Armstrong Medical, a tissue reconstructive material from BURGEON, an impactor handle from Exactech, a PET/CT scanner from GE Medical Systems, a device from Optimed, and immunoassay kits from Siemens. The MHRA emphasizes that recipients of FSNs must always act upon them.
Regulated entities, particularly healthcare providers and medical device manufacturers, should review these notices to ensure they are aware of any safety concerns or required actions related to the specified devices. While the MHRA publishes these FSNs for information, direct contact with the manufacturer is advised for specific questions. Compliance with manufacturer instructions is mandatory.
Source document (simplified)
Field Safety Notices: 09-13 February 2026
A list of Field Safety Notices: 09-13 February 2026
From: Medicines and Healthcare products Regulatory Agency Published 17 February 2026 Message type: Field safety notice Issued: 17 February 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 the 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: Ventilator Circuit (Update)
03 February 2026
Ventilator breathing circuit, single-use
Model: AMVC1792-070
MHRA reference: 38455421
Armstrong Medical: Ventilator Circuit
29 January 2026
Ventilator breathing circuit, single-use
MHRA reference: 38469533 2026/001/030/601/060
BURGEON: NOVUMA
10 February 2026
Polyethylene tissue reconstructive material
MHRA reference: 38482792 2026/002/011/601/033
Exactech: Ergo Impactor Handle
22 January 2026
MHRA reference: 38301731 2026/001/026/601/079
GE Medical Systems: OMNI Legend PET/CT
REF 40912
MHRA reference: 38486019 2026/001/020/601/113
Optimed: Tentos 4F
19 December 2025
MHRA reference: 38473763 2026/002/009/601/046
Siemens: IMMULITE 2000 EPO, IMMULITE EPO Control Module
February 2026
Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassay and Erythropoietin (EPO) IVD, control
MHRA reference: 38469063 2026/001/029/601/117
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Published 17 February 2026 Contents
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