| IRIC | Incident Reporting & Investigation Centre |
Reporting | Learning | Prevention
Circulation
DL1 NHS Incidents and alerts Safety Officers
DL2 Local Authority Incidents and alerts Safety Officers
DL3 Specialist Liaison Group
DL4 Product Specialists
DL5 General list (internal)
DL7 General list (external)
Outlook tags IRICSW$i0 (safety alert – general), IRICSW$i5 (field safety notices)
Dear colleague
This message is sent to share information on manufacturers’ field safety notices (FSNs) which have been brought to our attention. Manufacturers have a legal duty to distribute these notices to affected customers. This message does not affect the manufacturer’s FSN distribution, but it provides a reference source to check against.
You should always contact your supplier or the manufacturer if you are affected by a field safety notice listed below and have not received it from them. This will help ensure that you are not also missed from future FSN distributions.
Note that field safety notices will only be listed in the sections below if we have been made aware of them.
- Section 1 below lists FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).Section 2
- Section 2 lists changes to previously published FSNs.
- Section 3 lists selected FSNs and other relevant safety updates for estates, facilities or general products which have been brought to our attention through various sources including Office for Product Safety and Standards (OPSS).
Section 1: medical devices field safety notices (FSNs) 27/07/26 – 31/07/26
The following list of FSNs for medical devices is copied from the relevant MHRA web page. If you wish to browse or search for FSNs on the MHRA website, please click here. Alternatively, to search or browse a spreadsheet maintained by MHRA which details all FSNs issued since 2020, please click here.
- AusDiagnostics: RIDAPlex Respiratory Pathogens C 16 well Step 1 46212 MHRA reference: 40286573 2026/006/026/601/007
- Beckman Coulter: DxC 500i, DxC 500 AU Clinical Chemistry Analyzers 46220 Multiple clinical chemistry analyser IVD, laboratory, Chemiluminescent immunoassay analyser IVD MHRA reference: 40311671 2026/007/021/601/153
- BioScience: Genefill DX 46232 MHRA reference: 40374312 2026/007/029/601/061
- Maquet Cardiopulmonary: PIK 100#Insertion Kit, Guidewire 100 cm (Mat. 701047384) PIK 100-USA#Insertion Kit Guidewire 100 (Mat. 701053068) PIK 150#Insertion Kit, Guidewire 150 cm (Mat. 701047385) PIK 150-USA#Insertion Kit Guidewire 150 (Mat. 701053069) PIK dilator S# (Mat. 701054606) PIK dilator set L# (Mat. 701054427)Brand 46230 Vascular catheter introducer set MHRA reference: 40361995 2026/007/028/601/022
- W.L. Gore: GORE EXCLUDER Thoracoabdominal Branch Endoprosth 46204 MHRA reference: 40330955 2026/007/024/601/061
Section 2: updates and changes to previously published medical device FSNs
| Page summary | Update / change |
| List of Field Safety Notices from 29 June to 03 July 2026 | Updated FSN entry for ‘Philips: Allura and Azurion’ to include missing information. |
Section 3: estates, facilities or general products
1. Product Recall: Emerson Sempell GmbH Valve Fastener (2509-0175)
2. Product Safety Report: 100cm Jumbo Soft Plush Elephant sold via Amazon (2607-0141)
3. Product Recall: 3M Peltor Comtac VIII Headset (2607-0161)
4. Product Recall: Blair Tub Rust Velvet Armchair (2607-0195)
5. Product Withdrawal: Milton Baby Bottle Cleaner 500ml (2607-0040) updated
6. Product Recall: Kobe 2kw Oil-Filled 9 Fin Radiator (2606-0205) updated
Adverse Incidents
Incidents and near-misses should always be reported to local incident reporting and learning systems (often referred to as Datix, Healthcare Guardian, Evotix, SHE, etc.). However, IRIC also needs to be informed about incidents and near-misses when they involve:
- Medical devices, e.g. infusion pump, central line, hoist, care bed, x-ray machine, ventilator
- Software as a medical device, e.g. HEPMA
- In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, lateral flow test kit
- Estates and facilities, e.g. electrical installations, window restrictors, nurse call systems
- Social care equipment, e.g. mobile wheeled commode, powered rise and recline chair
- Personal protective equipment or PPE, e.g. visors, FFP3 respirators, aprons
We need incident reports so we can work with manufacturers and our partners to stop the same thing happening again. Health and care professionals can also report safety concerns about equipment and devices when an incident or near-miss has yet to occur. Information about how to report an incident to IRIC can be found here: https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/
Kind regards
Incident Reporting & Investigation Centre (IRIC)
Public Services Delivery Scotland
Gyle Square | 1 South Gyle Crescent
Edinburgh | EH12 9EB
m: 0131 275 7575
FAC406-212, 8B(i), Rev 8
——————————————————————————————————————————————————–
This email is intended for the named recipient only. If you have received it by mistake,
please (i) contact the sender by email reply; (ii) delete the email from your system; .
and (iii) do not copy the email or disclose its contents to anyone.
——————————————————————————————————————————————————–