Field Safety Notices: 8 -12 June 2026
List of Field Safety Notices for 8-12 June 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
Abiomed: Automated Impella Controller (AIC)
11 May 2026
Intracardiac circulatory assist axial-pump cathete
Model: 0042-0000
MHRA reference: 39771283 2026/006/008/601/101
Aesculap: ELAN 4 ELECTRO 2.35MM HANDPIECE
28 May 2026
Joint surgical power tool motorized handpiece
MHRA reference: 39756838 2026/005/021/601/120
ArcRoyal: BD Connecta Stopcock in ArcRoyal procedure packs
08 June 2026
Infusion stopcock
MHRA reference: 39785276 2026/006/009/601/057
Biocartis: Idylla MSI TestBrand
11 June 2026
MHRA reference: 39816068 2026/006/011/601/112
Boston Scientific: FARADRIVE Steerable Sheath
11 June 2026 97610227-FA
Vascular guide-catheter, single-use
MHRA reference: 39754930 2026/006/005/601/076
Boston Scientific: FARASTAR Pulsed Field Ablation Generator
11 June 2026 97586259-FA
MHRA reference: 39762593 2026/006/005/601/124
Boston Scientific: SCS Infinion CX Lead
17 June 2026 97046436-FA
MHRA reference: 39816022 2026/006/011/601/083
CONMED: AirSeal Access Ports
20 May 2026
Laparoscopic access cannula, single-use
MHRA reference: 39807190 2026/006/005/601/120
Intersurgical: Various BVM Resuscitators
11 June 2026
BVM Resuscitators
MHRA reference: 39776068
Olympus: SINGLE USE LIGATING DEVICE POLYLOOP UPDATE
29 April 2026
Polypectomy endoscopic ligator, single-use
Model: HX-400U-30
MHRA reference: 39791104 2025/011/004/601/056
Siemens: ARTIS icono ceiling
June 2026
Stationary angiographic x-ray system, digital
MHRA reference: 39753377 2026/006/005/601/096
SIS Medical: OPN NC
05 June 2026
Coronary angioplasty balloon catheter, basic
MHRA reference: 39755540 2026/006/005/601/144