Field Safety Notices (FSNs): 08/12/25 – 12/12/25

Manufacturers’ Field Safety Notices

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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)

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 but 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 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 2 lists FSNs for medical devices brought to our attention specifically by Medicines and Healthcare products Regulatory Agency (MHRA).

Section 1: estates, facilities or general products

1.     Product Safety Report: Flower Frail Baby Bath Chair Support sold via Amazon (2512-0105)

2.     Urgent safety check for 85,000 tumble dryers

3.     Product Recall: B&M Cream and Green Mug (2512-0106)

4.     Product Safety Alert: Baby Sleep Pillows (PSA8)

5.     Safety Alert issued for baby sleep pillows

6.     Product Safety Report: Elephant Baby Bath Seat sold via Vicedeal (2512-0112)

7.     Product Safety Report: TYRY.HU Blue Silicone Pacifier and Teething Chain with Clip sold via TikTok (2512-0118)

8.     Product Safety Report: SwimBoBo Soft Baby Swimming Float sold via TikTok and Amazon (2512-0115)

9.     Product Safety Report: Blue Bear Baby Sleeping Bag sold via TikTok (2512-0100)

10.   Product Safety Report: SINYA Teether with Clip sold via TikTok (2512-0099)

11.   Product Safety Report: Pink Unicorn Design Baby Swimming Float with Canopy 3+ Months sold via TikTok (2512-0117)

12.   Product Safety Report: SwimBoBo Space Rocket Pool Float sold via TikTok (2512-0101)

Section 2: medical devices 08/12/25 – 12/12/25

1. Baxter: Ambulatory Elastomeric Infusion Pumps 45992 MHRA reference: 37850863 2025/012/001/601/064
2. Etac: Molift Mover 205 & 300 / Molify Sling Bars 45981 Mobile patient lifting system, electric powered MHRA reference: 37870148 2025/011/026/601/022
3. MEDCAPTAIN MEDICAL TECHNOLOGY: BD neXus V700 Infusion Pump & S700 Syringe Pump 45992 V700: Infusion Pump; S700: Syringe Pump MHRA reference: 37923637 2025/012/008/601/002
4. Medtronic: A71200 Vanta Clinician Programmer Application December 2025 FA1512 Model: A71200 MHRA reference: 37897948 2025/011/005/601/016
5. Medtronic: AbreTM Venous Self-Expanding Stent System 45992 Iliofemoral vein stent Model: AB9U14060090, AB9G14100090, AB9U14100090, AB9G14120090, AB9U12080090, AB9G12060090, AB9G12100090, AB9U14080090, AB9G14080090, AB9G12080090, AB9U12060090 MHRA reference: 37896920 2025/011/025/601/097
6. Mint Medical: Mint Lesion 45974 MHRA reference: 37856200 2025/008/029/601/036
7. Olympus: SINGLE USE LIGATING DEVICE POLYLOOP 45968 Polypectomy endoscopic ligator, single-use Model: HX-400U-30 MHRA reference: 37944301 2025/011/004/601/056
8. Permobil: M and F series with Corpus seating system 45996 Electric-motor-driven wheelchair, occupant-control Model: M Corpus VS, M5 Corpus, M3 Corpus, F5 Corpus VS, F5 Corpus, F3 Corpus MHRA reference: 37922640 2025/012/010/601/054
9. SLE: SLE1500 & Interflow Gas Blender 45992 Neonatal CPAP unit Model: SLE1500 and Interflow MHRA reference: 37888109 2025/010/028/601/106
10. Unisurge: Pack Laparoscopic 45925 MHRA reference: 37946685 2025/010/007/601/084

The above 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. 

Section 3: updates and changes to previously published medical device FSNs

Adverse Incidents

Incidents and near-misses should always be reported to local incident management systems (often referred to as Datix, Ullyses, 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
• In vitro diagnostic devices or IVDs, e.g. blood analyser, reagent, SARS-CoV-2 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)

NHSScotland Assure

NHS National Services Scotland

Tel: 0131 275 7575 | nss.iric@nhs.scot 

IRIC operates incident learning and prevention systems for health and care technologies (medical devices, IVDs, estates, facilities, social care equipment and PPE). Find out more in CEL43 (2009), explore our educational content on Turas Learn or visit our website to: report an incident, find our safety alerts, or watch our short Intro to IRIC video

We are NHS National Services Scotland. We offer a wide range of services and together we provide national solutions to improve the health and wellbeing of the people of Scotland. Find out more in our NSS Strategic Framework 2024-2026

FAC406-212, 8B(i), Rev 7

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