Field Safety Notices: 30 March - 3 April 2026
Summary
MHRA published a weekly summary of Field Safety Notices received from medical device manufacturers for 30 March - 3 April 2026. The listing includes four FSNs: Abbott Afinion HbA1c diagnostic devices, Boston Scientific ACCOLADE cardiac devices, Ivoclar Vivadent Adhese 2 dental adhesives, and Resoundant Acoustic Driver System imaging devices. MHRA clarifies the listings are for information only and recommends contacting manufacturers directly with questions.
What changed
MHRA published its weekly Field Safety Notice (FSN) summary covering 30 March - 3 April 2026. Four FSNs were listed: Abbott Afinion HbA1c diagnostic devices (HbA1c test systems), Boston Scientific ACCOLADE cardiac devices (four customer letters), Ivoclar Vivadent Adhese 2 dental adhesives (customer and distributor letters), and Resoundant Acoustic Driver System diagnostic imaging devices.\n\nHealthcare providers and facilities using these devices should monitor for related FSNs directly from manufacturers, as MHRA publishes these notices for information only. While this is a routine weekly listing, any facility using affected devices should treat manufacturer-issued FSNs as requiring action. The notices may indicate product defects, usage restrictions, or required modifications to ensure patient safety.
What to do next
- Review FSNs for any medical devices currently in use
- Contact manufacturers directly for questions about specific FSNs
- Implement any required corrective actions specified in received FSNs
Archived snapshot
Apr 8, 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: 30 March - 3 April 2026
List of Field Safety Notices for 30 March - 3 April 2026
From: Medicines and Healthcare products Regulatory Agency Published 8 April 2026 Message type: Field safety notice Issued: 8 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
Abbott: AfinionTM HbA1c
04 February 2026
Model: HbA1c, HbA1c Control, HbA1 Calibration verification
MHRA reference: 39058213 2026/003/019/601/102
Boston Scientific: ACCOLADE
March 2026
MHRA reference: 38991805 2026/003/013/601/054 Letter 1
MHRA reference: 38991805 2026/003/013/601/054 Letter 2
MHRA reference: 38991805 2026/003/013/601/054 Letter 3
MHRA reference: 38991805 2026/003/013/601/054 Letter 4
IVOCLAR VIVADENT: Adhese 2
Ref 03-2026-001-R
MHRA reference: 39028557 2026/003/031/601/016 Customer Letter
MHRA reference: 39028557 2026/003/031/601/016 Distributor Letter
Resoundant: Acoustic Driver System
17 March 2026
Model: RESYS4001-RESYSAB
MHRA reference: 38995434 2026/002/026/601/160
Updates to this page
Published 8 April 2026 Contents
Related changes
Get daily alerts for MHRA Drug & Device Alerts
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from MHRA.
The plain-English summary, classification, and "what to do next" steps are AI-generated from the original text. Cite the source document, not the AI analysis.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when MHRA Drug & Device Alerts publishes new changes.