Field Safety Notices: 1-5 June 2026
List of Field Safety Notices for 1-5 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 . FSNs before this date are on the
Berchtold: CHROMOPHARE
May 2026
Model: CH00000001
MHRA reference: 2026/005/019/601/140
Bolton Medical: RelayPro Thoracic Stent-Graft System (NBS)
FSN2026-002
Thoracic aorta stent-graft
Model: 28-N4-XX-XXX-XXS
MHRA reference: 2026/004/030/601/065
EKF-diagnostic: Chip Sensor Lactate, Type II
18 May 2026
Model: 5206-3029
MHRA reference: 2026/005/019/601/146
ELLA-CS: SX-ELLA Stent Danis (Danis stent)
07 May 2026
Polymer-metal oesophageal stent
MHRA reference: 2026/004/029/601/071
Fresenius: Sleep Safe Harmony
28 May 2026
Model: M206001
MHRA reference: 2026/006/003/601/068
Ivor Shaw Limited t/a Pennine Healthcare: B.Braun Procedure Packs (Various)
03 June 2026
MHRA reference: 2026/006/003/601/124
Löwenstein: LEONI 4
June 2026
Model: 0730000
MHRA reference: 2026/006/003/601/076
Löwenstein: elisa 300, elisa 500, elisa 600, elisa 800 (VIT)
May 2026
Critical Care Ventilator
MHRA reference:
Medtronic: DLP One-Piece Pediatric Arterial Cannulae
June 2026 FA1567
Cardiopulmonary bypass/extracorporeal membrane
MHRA reference: 2026/005/019/601/065
Medtronic: Harmony
May 2026 FA1565
Model: HARMONY-DCS
MHRA reference: 2026/005/021/601/068
PolyNovo Biomaterials: NovoSorb BTM (Biodegradable Temporising Matrix)
26 May 2026
Synthetic wound matrix dressing
Model: BTM-0505
MHRA reference: 2026/004/001/601/170
Stryker: INZONE DETACHMENT SYSTEM
April 2026
MHRA reference: 2026/004/016/601/040