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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) 08 to 12 mmmm 2026
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.
- Abiomed: Automated Impella Controller (AIC) 46153 Intracardiac circulatory assist axial-pump cathete Model: 0042-0000 MHRA reference: 39771283 2026/006/008/601/101
- Aesculap: ELAN 4 ELECTRO 2.35MM HANDPIECE 46170 Joint surgical power tool motorized handpiece MHRA reference: 39756838 2026/005/021/601/120
- ArcRoyal: BD Connecta Stopcock in ArcRoyal procedure packs 46181 Infusion stopcock MHRA reference: 39785276 2026/006/009/601/057
- Biocartis: Idylla MSI TestBrand 46184 MHRA reference: 39816068 2026/006/011/601/112
- Boston Scientific: FARADRIVE Steerable Sheath 11 June 2026 97610227-FA Vascular guide-catheter, single-use MHRA reference: 39754930 2026/006/005/601/076
- Boston Scientific: FARASTAR Pulsed Field Ablation Generator 11 June 2026 97586259-FA MHRA reference: 39762593 2026/006/005/601/124
- Boston Scientific: SCS Infinion CX Lead 17 June 2026 97046436-FA MHRA reference: 39816022 2026/006/011/601/083
- CONMED: AirSeal Access Ports 46162 Laparoscopic access cannula, single-use MHRA reference: 39807190 2026/006/005/601/120
- Intersurgical: Various BVM Resuscitators 46184 BVM Resuscitators MHRA reference: 39776068
- Olympus: SINGLE USE LIGATING DEVICE POLYLOOP UPDATE 46141 Polypectomy endoscopic ligator, single-use Model: HX-400U-30 MHRA reference: 39791104 2025/011/004/601/056
- Siemens: ARTIS icono ceiling 46174 Stationary angiographic x-ray system, digital MHRA reference: 39753377 2026/006/005/601/096
- SIS Medical: OPN NC 46178 Coronary angioplasty balloon catheter, basic MHRA reference: 39755540 2026/006/005/601/144
Section 2: updates and changes to previously published medical device FSNs
| Page summary | Update / change |
| None | n/a |
Section 3: estates, facilities or general products
a) Product Recall: Dunelm Seasonal Doorstops (2606-0136)
b) Product Safety Report: Elephant Shape Sleep Pillow sold via Wish (2606-0131)
c) Product Recall: Puggle Airlite 3-In-1 Folding Travel Cot and Playpen with Bassinette and Airlite 2-In-1 Folding Travel Cot & Playpen (2606-0135)
d) Product Recall: 4 Gang Extension Lead sold via eBay (2603-0174)
e) Product Safety Report: Dongguan Mumiy Technology Industry Co Ltd Colobyby Baby Self Feeding Bottle (2606-0119)
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
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