Field Safety Notices (FSNs): 22/06/26 – 26/06/26

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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) 22/06/26 – 26/06/26

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. 

1. Baxter: Homechoice Automated PD set with Cassette 46192 Tubing set, peritoneal dialysis MHRA reference: 39917600 2026/006/018/601/044
2. BioFire Diagnostics: BioFire Joint Infection (JI) Panel 46142 Multiple-type respiratory pathogen nucleic acid Model: RFIT-ASY-0138 MHRA reference: 39948946 2026/004/023/601/023
3. Boston Scientific: Radial Jaw 4 Biopsy Forceps 46203 Flexible endoscopic biopsy forceps, single-use MHRA reference: 39973308 2026/006/024/601/084
4. DH Healthcare: ORBIS Medication 3.x 46197 MHRA reference: 39975505 2026/006/024/601/014
5. GE Healthcare: Giraffe and Panda iRes Warmers Ref 32102 MHRA reference: 40011384 2026/006/002/601/038
6. Immucor: LIFECODES LSA Class II Kit 46174 HLA class II antigen tissue typing IVD, kit MHRA reference: 39972915 2026/006/023/601/032
7. Instrumentation Laboratory: HemosIL AcuStar ADAMTS13 Activity 46191 ADAMTS13 activity IVD kit MHRA reference: 39959529 2026/006/023/601/085
8. Löwenstein: Leoni Plus 46174 MHRA reference: 39987026 2026/006/025/601/076
9. Maquet Cardiopulmonary: Custom Tubing Packs (CTPs) 46195 Tubing Set, heart-lung bypass MHRA reference: 39959533 2026/006/023/601/053
10. Medline Industries: MEDSTOP 46196 MHRA reference: 39959847 2026/006/023/601/061
11. Medtronic: EOPA Elongated One-Piece Arterial Cannulae June 2026 FA1573 MHRA reference: 39985394 2026/006/009/601/030
12. Scoozy: Sterling S800 46195 Assistive scooter, electric-motor-driven Model: S800 MHRA reference: 39939130 2026/006/018/601/073
13. Serosep: HistoPot 5L jerry can 46171 Neutral buffered formalin IVD MHRA reference: 39964635 2026/005/027/601/137
14. Siemens: Atellica CH Diazo Total Bilirubin (D_TBil) 46113 Total bilirubin IVD, kit, spectrophotometry MHRA reference: 39953591 2025/007/002/601/055
15. Stryker: 12cm iQ Claw 46174 MHRA reference: 39954909 2026/006/019/601/065

Section 2: updates and changes to previously published medical device FSNs

Section 3: estates, facilities or general products

1. Product Recall: Light-Blue or Low-Visibility Baby Floats sold via TikTok (2606-0178)
2. Product Recall: Toy-Like Baby Floats sold via TikTok (2606-0177)
3. Product Recall: Baby Neck Floats sold via TikTok (2606-0175)
4. Product Recall: Baby Floats with Canopies sold via TikTok (2606-0176)

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

e: nss.iric@nhs.scot

m: 0131 275 7575

publicservicesdelivery.scot

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

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