Field Safety Notices: 28 April to 2 May 2025
Source: gov.uk (2025-05-06)

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 the latest FSNs (https://mhra-gov.filecamp.com/s/o/S9fn1618LuA1H1Et)

View a list of FSNs published since January 2020 (https://mhra-gov.filecamp.com/s/9g5cLjjFatXruS5U/d)

View FSNs since November 2014 (https://mhra-gov.filecamp.com/s/ZOxdOzRzP22RziUW/fo). FSNs before this date are on the National Archives website (https://webarchive.nationalarchives.gov.uk/*/http:/www.mhra.gov.uk/index.htm)

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: 35464582 (https://mhra-gov.filecamp.com/s/d/9s7V9h5pPKq2UebU) - Customer reply form

MHRA reference: 35464582 (https://mhra-gov.filecamp.com/s/d/vJQmlSMLowhWmbmA) – FSN - 2025/004/xx-xxxx-xxxx

Beckman Coulter Inc.: AU/DxC AU Creatinine

15 April 2025

FSN-001294

Creatinine IVD, kit, spectrophotometry REF OSR6178

Model: Refer to FSN

MHRA reference: 35457938 (https://mhra-gov.filecamp.com/s/d/xNdSQUexIOkr1RyA) 2025/004/xx-xxxx-xxxx – FSN

MHRA reference: 35457938 (https://mhra-gov.filecamp.com/s/d/uUwaZaV2wS4BJNVH) Vigilance response form

Biomedical Data Solutions Limited: ORTHO CONNECT™

1 April 2025

Laboratory Instrument Application Software IVD

Model: Refer to FSN

MHRA reference: 35453650 (https://mhra-gov.filecamp.com/s/d/vP9NbQ7x0iCZY2IE) 2025/004/xx-xxxx-xxxx – Acknowledgement form

MHRA reference: 35453650 (https://mhra-gov.filecamp.com/s/d/h6bTIzapaOeOYVAr) 2025/004/xx-xxxx-xxxx - FSN

ETHICON ENDO-SURGERY LLC: ENDOPATH ECHELON™ 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: 35416571 (https://mhra-gov.filecamp.com/s/d/3kBb7aqwrgV7PS85) 2025/004/xx-xxxx-xxxx

LeMaitre Vascular: TufTex® Over-the-Wire Embolectomy Catheter, Pruitt® Occlusion Catheter, Pruitt® Irrigation Occlusion Catheter

28 April 2025

Embolectomy Catheter, Occlusion Catheter

Model: Refer to FSN

MHRA reference: 35429539 (https://mhra-gov.filecamp.com/s/d/9YW8KhrFs1Y7bcs7) 2025/004/xx-xxxx-xxxx

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: 35466496 (https://mhra-gov.filecamp.com/s/d/OJyEKAIY5K51gLhF) 2025/004/xx-xxxx-xxxx

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: 35466586 (https://mhra-gov.filecamp.com/s/d/7A03w8vERY3hufhb) 2025/004/xx-xxxx-xxxx

Savantini Limited: Ear Clip Electrodes

26 March 2025

Recall of Ear Clip Electrodes Due to Safety Concerns

MHRA reference: 35464563 (https://mhra-gov.filecamp.com/s/d/lDdAl8nEOqfS6y87) 2025/004/xx-xxxx-xxxx

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: 35464563 (https://mhra-gov.filecamp.com/s/d/Tz5gIqrarmFpJqzo) 2025/004/xx-xxxx-xxxx

Synthes GmbH: Cannulated Screws Ø 3.5 mm (3 lots)

29 April 2025

Orthopaedic bone screw (non-sliding)

Model: Refer to FSN

MHRA reference: 35441612 (https://mhra-gov.filecamp.com/s/d/kvjfYUKZOh1zfWtT)

Vyaire Medical, Inc.: AirLife Infant Heated Wire Circuits

11 April 2025

Conduit for respiratory gas, single use

Model: AH165 and AH265

MHRA reference: 35415881 (https://mhra-gov.filecamp.com/s/d/fOadI6rPneTw1WzV) 2025/004/011/601/089