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Manufacturers’ Field Safety Notices
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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 27/12/2025
1. My safety: smart connected products
2. Product Recall: Xiaomi 33W Power Bank 20000mAh with Integrated Cable (2510-0232)
3. Product Recall: Kingfisher Site Hallissey Dark Brown Dealer Boot (2511-0153)
4. Product Safety Report: Wooden Baby Teether Ring sold via TikTok (2512-0116)
5. Product Safety Report: Baby Bath Stand sold via Wish (2512-0184)
6. Product Safety Report: Baybee Newborn Bath Seat sold via Desertcart (2512-0187)
7. Product Safety Report: CuteStone 2 in 1 Baby Walker sold via Amazon (2512-0200)
8. Product Safety Report: Dongguan Xike Silicone Technology Dummy Clip sold via Shein (2509-0064)
9. Product Recall: Costway BY213-BS021-C 2 Socket 1 USB and 1 USBC Extension Lead sold via Amazon, eBay, The Range and B&Q Marketplace (2502-0012)
10. Product Safety Report: Winter Swaddle Wrap Sleeping Bag (2503-0138)
11. Product Safety Report: Knitted Sleeping Bag with Hood (2504-0011)
12. Product Safety Report: GBP-FLO 6M Head Circulating Pump (2512-0291)
13. Product Safety Report: Goose Baby Pillow sold via Amazon (2502-0017)
14. Product Safety Report: Baby Pillow with Patting Function sold via Amazon (2502-0016)
15. Product Recall: Next Cora 5LT Flush Ceiling Light (2512-0232)
Section 2: medical devices 29/12/2025 to 02/01/2026
- Maquet Cardiopulmonary: BS 3/8×3/32 L1.7 16 December 2025 Cardiopulmonary bypass system air bubble/fluid level detector MHRA reference: 38087721 2025/012/029/601/056
- Thora Tech: monsoon 4 24 December 2025 Ventilator, High Frequency Model: double+ MHRA reference: 38081102 2025/012/019/601/042
- Unisurge: Procedure Packs 23 December 2025 MHRA reference: 38082679 2025/012/024/601/024
- WAK-Chemie Medical: CryoSure-DMSO 6 x 70 ml Vials 19 December 2025 Blood storage solution, freezing Model: WAK-DMSO-70 MHRA reference: 38088029 2025/012/029/601/080….
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
| Page summary | Change(s) made |
| n/a | n/a |
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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