Field Safety Notices (FSNs): 05/01/26 – 09/01/26

Manufacturers’ Field Safety Notices

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)

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: Metador Defender Fire Doorsets (2512-0236)

2.     Product Recall: Primark Baby Bear and Balloon Soother Clips (2601-0060)

3.     Product Recall: Tinc Festive Santa Bottle sold via Waitrose (2601-0057)

Section 2: medical devices 05/01/26 – 09/01/26

1. Cardinal Health 200: Chest Drainage Units & accessories 46020 Drainage Systems With Reservoir MHRA reference: 38140305 2026/001/005/601/015
2. CareDx: Olerup QTYPE 11 46008 MHRA reference: 38153616 2025/012/017/601/070
3. Diagnostica Stago: Asserachrom HPIA 45996 PF4-heparin complex antibody IVD, kit MHRA reference: 38153328 2025/012/005/601/094
4. Genome Diagnostics: NGSengine 46010 NUCLEIC ACID TESTING INSTRUMENT EXCEPT MICRO-ARRAY MHRA reference: 38143455 2025/012/019/601/114
5. Microbiologics: KWIK-STIK and LYFO DISK controls 46020 Multiple bacteria species identification control Model: KWIK-STIK 2-Pack Campylobacter jejuni subsp. jejuni derived MHRA reference: 38143361 2025/012/030/601/061
6. Olympus: Thunderbeat 46030 Soft-tissue ultrasonic surgical system holder/tip Model: TB-0535FCS,TB-0545FCS,TB-0520FCS, TB-0535PC, TB-0520IC, TB-0510IC MHRA reference: 38120054 2026/001/002/601/023
7. Olympus: Single Use Electrosurgical Knife 46031 Laparoscopic electrosurgical scissors Model: KD-645L, KD-640L MHRA reference: 38131509 2026/001/005/601/022
8. Olympus: Resection sheath; Inner Sheath; Sheath 46036 Resectoscopes Model: Resection sheath: A22014A, A22014T, A22041A, A22041T, A22042A, A22042T, A22043A, A22043T, A2666, A2666T, A42011AInner Sheath: A22040A, A22040T, A2660, A2660T, A4741, A2641, A2642, WA22017A, WA22017TSheath: A37004A MHRA reference: 38152676 2026/001/007/601/007

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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