Five Medical Device Field Safety Notices Published April 13–17
Summary
MHRA published five Field Safety Notices (FSNs) covering the period 13–17 April 2026, affecting five distinct medical devices: Biosense Webster's cardiac irreversible electroporation catheter (09 March 2026), Dexcom's G7 iOS CGM App and Dexcom ONE+ iOS CGM App, Getinge's Stericool sterilant agent (April 2026), The Binding Site Group's EXENT Analyser, and Zimmer's Disposable Mixing Bowls. The notices are published by MHRA for information only; recipients are directed to contact the respective manufacturers directly with questions.
“If you receive a field safety notice (FSN) from a manufacturer you must always act on it.”
About this source
The Medicines and Healthcare products Regulatory Agency is the UK's medicines and medical devices regulator. MHRA publications include drug safety alerts, device field safety notices, Class 1-4 defect recalls, guidance updates, and the monthly medicines shortage list. Around 55 publications a month. Device field safety notices in particular are useful because MHRA often publishes them hours before other European regulators (ANSM, BfArM) surface the same recall. Watch this if you manufacture or distribute medicines or medical devices in the UK and EU, run a hospital pharmacy, advise on MHRA licensing, or follow post-market surveillance signals across European markets.
What changed
MHRA published five Field Safety Notices (FSNs) from 13–17 April 2026 covering five distinct medical devices: Biosense Webster cardiac electroporation catheter, Dexcom G7 and Dexcom ONE+ iOS glucose monitoring apps, Getinge Stericool sterilant agent, Binding Site EXENT analyser, and Zimmer Disposable Mixing Bowls. The document clarifies that FSNs are issued by manufacturers and that MHRA publishes them for information only. Healthcare providers and medical device users who receive FSNs directly from manufacturers must act on them. Questions about specific FSNs should be directed to the named manufacturers.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Field Safety Notices: 13 to 17 April 2026
List of Field Safety Notices from 13 to 17 April 2026.
From: Medicines and Healthcare products Regulatory Agency Published 22 April 2026 Message type: Field safety notice Issued: 21 April 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
Biosense Webster: Dual Energy THERMOCOOL SMARTTOUCH SF Bi-Direction
09 March 2026
Cardiac irreversible electroporation system catheter
MHRA reference: 39153929 2026/003/017/601/006
Dexcom: G7 iOS CGM App and Dexcom ONE+ iOS CGM App
Ref FAS-SD-26-001
Percutaneous glucose monitoring system
MHRA reference: 39204335 2026/003/026/601/111 G7 iOS CGM App FSN
MHRA reference: 39204335 2026/003/026/601/111ONE+ iOS CGM App FSN
Getinge: Stericool Sterilant Agent, ST240
April 2026
Hydrogen peroxide device sterilant
MHRA reference: 39191143 2026/004/003/601/033
The Binding Site Group Limited: EXENT Analyser
14 April 2026
MHRA reference: 39193589 2026/004/006/601/007
Zimmer: Disposable Mixing Bowls with Spatula
14 April 2026
MHRA reference: 39179696 2026/004/014/601/076
Updates to this page
Published 22 April 2026
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