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
Siemens Healthineers: ACUSON Juniper and ACUSON Juniper Select Ultrasound systems
08 February 2024
General-purpose ultrasound imaging system
Model: 11335791, 11653093 (System IVK: 11335791)
MHRA reference: 32819130 2024/002/027/601/057
Aidence: Veye Lung Nodules
27 February 2024
Model: 3.22.0
MHRA reference: 28038186
Arjo: IndiGo Intuitive Drive Assistance
14 February 2024
Accessory for basic electric hospital beds
Model: INDI-XXX
MHRA reference: 28028412
Baxter: Flo-Rester, Flo-Thru, Vascular Probe, Ma Recette
29 February 2024
Surgical intravascular shunt
MHRA reference: 28043281 Letter
MHRA reference: 28043281 FSN
BD: BodyGuard MicroSet
26 February 2024
Electric infusion pump admin set,single use
MHRA reference: 28028023
Beckman Coulter: DxA Automation System / DxA Aliquoter
23 February 2024 FSN-24006
Specimen processing instrument IVD, automated
MHRA reference: 28043275
Beckman Coulter: Access Substrate
23 February 2024
Chemiluminescent substrate reagent IVD
Model: 81906
MHRA reference: 28043269
bioMrieux: BIOFIRE Pneumoniaplus (PNplus) Panel
08 February 2024
Multiple-type respiratory pathogen nucleic acid
Model: RFIT-ASY-0142 (PNplus, 30-pack), RFIT-ASY-0143 (PNplus, 6-pack)
MHRA reference: 27943715
bioMrieux: MUELLER HINTON E AGAR
26 Jan 2023
Mueller-Hinton agar antimicrobial susceptibility
MHRA reference: 27942675
BVI: 581012 - IRRIGATION HANDLE (20/SP)
13 February 2024
MHRA reference: 28029327
CONMED: HIP PRESERVATION SYSTEM SIGNATURE SERIES
09 February 2024
Arthroscopic shaver system blade, single-use
MHRA reference: 28043125
Cook: Dilators - Coons Taper, EntuitSecure Adjustable Gastrointestinal Suture Anchor Sets, Chiba Biopsy Needles
28 February 2024
Model: JCD22.0-38-20-COONS, GIAS-SRM-ADJ-2, DCHN-22-15.0, DCHN-22-15.0-U
MHRA reference: 28028797
LINK: OptiStem, Rasp Handle Stainless Steel
27 February 2024
Model: 17-5220/01
MHRA reference: 28040570
Luminex: NxTAG Respiratory Pathogen Panel
25 January 2024
MHRA reference: 28038177 Letter
MHRA reference: 28038177 FSN
Medicina: ENFit double-lumen polyurethane Replogle tube
12 February 2024
Model: NF02L
MHRA reference: 28030507
Olympus: SOLTIVE SuperPulsed Laser System
28 February 2024
General/multiple surgical solid-state laser system
Model: TFL-PLS, TFL-SLS
MHRA reference: 28029779
Randox: MICROALBUMIN CALIBRATOR SERIES (mALB CAL)
31 January 2024
Microalbumin IVD, calibrator
MHRA reference: 28028402
RaySearch Laboratories: RayStation
23 February 2024
Model: 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A
MHRA reference: 28043273
Roche: t 511/ t 711: PT-aPTT
April 2023
MHRA reference: 27919638
Siemens Healthineers: ACUSON Redwood ultrasound system
Ref: US005-24-S + US011-12-24-S
General-purpose ultrasound imaging system
Model: 11503314
MHRA reference: 28037799