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
ACE MEDICAL DEVICES: BLADDER EVACUATOR
03 April 2024
Bladder evacuator, single-use
Model: Universal
MHRA reference: 29516856
B Braun: ACETABULAR AND HEAD IMPLANTS
22 April 2024
Non-constrained polyethylene acetabular line
Model: NV302E; NV315ENV304E
MHRA reference: 29299354
Baxter: ProBP 3400, Spot Vision Screener and Power Cords
24 April 2024
MHRA reference: 29440148 FSN
MHRA reference: 29440148 Letter
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
24 April 2024
Chemiluminescent immunoassay analyzer IVD
Model: C11137
MHRA reference: 29516626
Cadwell: Cascade IOMAX Cortical Module
23 April 2024
Neurophysiologic monitoring system
MHRA reference: 29306814
Draeger: Infinity Acute Care System (M540)
April 2024
Physiological Monitoring Systems
Model: MS20407
MHRA reference: 29296585
Elekta: Disposable Biopsy Needle Kit
April 2024
Stereotactic Surgery System, Neurological
Model: 911933 50398-01, 307165, 60377-02, 60377-01, 50376-01, 14001050, 1002248
MHRA reference: 29517226
Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e
23 April 2024
Anesthesia system
MHRA reference: 29480963
HORIBA: ABX Pentra Urea CP
25 March 2024
Urea IVD, reagent
Model: A11A01641 / 1220001641
MHRA reference: 29434100
Intersurgical: Various Mapleson F Anaesthetic Breathing Systems
24 April 2024
Anaesthesia breathing circuit, single-use
MHRA reference: 29437107
Intuitive: SureForm45/60, Cannula Seal, Arm Drape, Obturator
19 March 2024
Robotic Surgical System
Model: 480445-04; 480460-09; 470015-07, 420023-03, 470361-08
MHRA reference: 29312113
Medline: Electrosurgical Electrode
FSN 24-02
MHRA reference: 29296734
Medtronic: Catheter, Dilation - 30mm
April 2024 FA1413
Gastrointestinal/biliary dilation balloon catheter
Model: ES-330
MHRA reference: 29517643
Philips: Igenia with Evolution Upgrade
19 April 2024
Magnetic Resonance Imaging (MRI) unit
Model: 782116, 782117
MHRA reference: 29517171
Philips: PIC iX, PIC iX Expand
2024-CC-HPM-013
Model: 866389, 866390
MHRA reference: 29300345