Medicines Healthcare Products Regulatory Agency
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
Beckman Coulter: DxA 5000 Automation System
12 June 2023
Specimen processing instrument IVD, automated
MHRA reference: 5323189
bioMrieux: MYLA V4.8 SOFTWARE; MYLA V4.9 SOFTWARE
15 February 2023
Laboratory instrument/analyser application software
MHRA reference: 5319742
HS DOMS GmbH: HS 810
28 March 2023
MHRA reference: 5314023
Integra: Surgimend / Primatrix
30 May 2023
Extra-gynaecological surgical mesh/Collagen Matrix
MHRA reference: 5302965
Intuitive: Tip-Up Fenestrated Grasper
ISIFA2023-02-R
Robotic surgical forceps
Model: 470347-12
MHRA reference: 5314523
Medtronic: Durepair Dura Regeneration Matrix
June 2023
Dura mater graft, bovine
Model: 61100, 61105, 61106, 61110, 61111
MHRA reference: 5319571
OLYMPUS: HF-resection electrode
16 June 2023
Electrodes, Electrosurgical
MHRA reference: 5321616
QIAGEN: NeuMoDx Cartridge
May 2023
MHRA reference: 5314266
Randox: Urea Enzymatic Kinetic Assay
09 June 2023
Urea IVD, kit, enzyme spectrophotometry
MHRA reference: 5314857
Samsung: GM85
FSN-GM85_230228-1
Mobile Digital Batteries X-ray Units
MHRA reference: 5295225
Siemens: Cios Select
May 2023
Mobile X-ray system intended for angiography
Model: 11515088
MHRA reference: 5317142
Stryker: AIRO CT SCANNER
June 2023
MHRA reference: 5317111
Talley: Venturi
QRN1006
Negative pressure wound therapy system
Model: Venturi Compact and Venturi MiNO
MHRA reference: 5323149
Tosoh: GX Assay Kit
03 May 2023
BUFFERS (UNASSIGNABLE), SUPPLEM. REAG
MHRA reference: 5203495