Field Safety Notices: 28 April to 2 May 2025
List of Field Safety Notices from 28 April to 2 May 2025.
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
Abbott Molecular, Inc.: Alinity m Resp-4-Plex AMP Kit
24 April 2025
REF: FA-AM-APR2025-307B
List Number: 09N79-090
Lot Numbers: 409383, 410627, 411921
MHRA reference: 聽聽 - Customer reply form
MHRA reference: 聽聽 鈥� FSN -聽 2025/004/030/601/019
Beckman Coulter Inc.: AU/DxC AU Creatinine
15 April 2025
FSN-001294
Creatinine IVD, kit, spectrophotometry REF OSR6178
Model: Refer to FSN
MHRA reference: 聽聽 2025/004/029/601/086 鈥� FSN
MHRA reference: 聽聽 Vigilance response form
Biomedical Data Solutions Limited: ORTHO CONNECT鈩�
1 April 2025
Laboratory Instrument Application Software IVD
Model: Refer to FSN
MHRA reference: 聽聽 2025/004/029/601/063 鈥� Acknowledgement form
MHRA reference: 聽聽 2025/004/029/601/063 - FSN
ETHICON ENDO-SURGERY LLC: ENDOPATH ECHELON鈩� Vascular White Reload for Advanced Placement Tip (35 mm, 4 Row)
FSCA# FA-0000099
Surgical staple loading unit, non-cutting
Model: Refer to FSN
MHRA reference: 聽聽 2025/004/025/601/016
LeMaitre Vascular: TufTex庐 Over-the-Wire Embolectomy Catheter, Pruitt庐 Occlusion Catheter, Pruitt庐 Irrigation Occlusion Catheter
28 April 2025
Embolectomy Catheter, Occlusion Catheter
Model: Refer to FSN
MHRA reference: 聽聽 2025/004/022/601/075
Medtronic: Midas Rex Legend Tool 8CM 2.3MM Spiral F2/8TA23S Tool Insertion
April 2025
Medtronic Reference: FA1487
Instruments for motorised neurosurgery systems
Model: F2/8TA23S
MHRA reference: 聽聽 2025/004/030/601/053
Mercado Medic AB: Medic Back Recliner for REAL 9000 PLUS, REAL 9200 TWIN and REAL 6100 PLUS
28 April 2025
FSN Ref: FSN-S10858
Back Recliner
Model: Refer to FSN
MHRA reference: 聽聽 2025/004/030/601/009
Savantini Limited: Ear Clip Electrodes
26 March 2025
Recall of Ear Clip Electrodes Due to Safety Concerns
MHRA reference: 聽聽 2025/004/030/601/048
Savantini Limited: Universal TENS Machine
26 March 2025
Recall of Ear Clip Electrodes Due to Safety Concerns
Affected Batches: Orders placed between 1st September 2023 and 31st August 2024
MHRA reference: 聽聽 2025/004/030/601/048
Synthes GmbH: Cannulated Screws 脴 3.5 mm (3 lots) 聽
29 April 2025
Orthopaedic bone screw (non-sliding)
Model: Refer to FSN
MHRA reference:
Vyaire Medical, Inc.: AirLife Infant Heated Wire Circuits
11 April 2025
Conduit for respiratory gas, single use
Model: AH165 and AH265
MHRA reference: 聽聽 2025/004/011/601/089