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Field Safety Notices (FSNs): 24/08/26 – 28/08/26

IRICIncident Reporting &
Investigation Centre

Reporting | Learning | Prevention

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DL2 Local Authority Incidents and alerts Safety Officers

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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: medical devices field safety notices (FSNs) 24/08/26 – 28/04/26

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. Aesculap: Metha CoCr modular neck system 46260 Femoral head/stem prothesis adaptor MHRA reference: 40647164 2026/008/026/601/112
  2. Bausch & Lomb: EyeFill C 46235 MHRA reference: 40655224 2026/008/027/601/106
  3. BioFire Diagnostics: BIOFIRE PN Panel plus, BIOFIRE JI Panel 46256 Multiple-type respiratory pathogen nucleic acid Model: PNplus: RFIT-ASY-0143 (30 pack), RFIT-ASY-0142 (6 pack); JI: RFIT-ASY-0138 (30 pack), RFIT-ASY-0135 (6 pack)ASY-0104 MHRA reference: 40610695 2026/008/021/601/024
  4. Convatec: Esteem Body 1 Piece Soft Convex Ostomy Pouches 46204 One-piece urostomy bag, open-ended MHRA reference: 40647867
  5. Datex-Ohmeda: Aisys and Aisys CS2 Ref 34147 MHRA reference: 40622243 2026/008/020/601/010
  6. Datex-Ohmeda: Carestation 850, Carestation 850c Ref 34148 Anaesthesia workstation MHRA reference: 40657877 2026/008/020/601/010
  7. Datex-Ohmeda: CSCS V3 MAS800 Desktop,CSCS V3 MAI800 Integrated Ref 36173 Centralized Patient Monitor MHRA reference: 40633163 2026/008/021/601/056
  8. Drägerwerk: VentStar Resus Neo, VentStar Resuscitaire 46235 Tubes / Tubing Model: MP00310, MP00311 MHRA reference: 40607245 2026/008/020/601/092
  9. ICU Medical: CADD Medication Cassette Reservoirs with NRFit 46262 Infusion pump cassette MHRA reference: 40630462 2026/008/025/601/011
  10. Medtronic: Newport HT70 Ventilator / Newport HT70 Ventilator August 2026 ref FA1479 Neonatal/adult Intensive care ventilator MHRA reference: 40558257 2025/005/021/601/034
  11. Mölnlycke Health Care: Procedure Trays Containing Pennine Suction Connecting Tubes 46255 MHRA reference: 40607869 2026/008/021/601/093
  12. Philips: BV Endura, BV Pulsera, BV Vectra, Veradius, Zenition 46259 Interventional Fluoroscopic X-Ray System Model: 718075, 718094, 718095, 718130, 718131, 718132, 718400, 718096, 718133, 718401, 718076, 718134 MHRA reference: 40653768 2026/008/025/601/127
  13. Siemens Healthcare Diagnostics: Atellica CH Revised C-Reactive Protein (RCRP) 46235 MHRA reference: 40607506 2026/008/012/601/131
  14. Stryker: Connecting Rod Hoffmann II Micro 46174 Model: 50796090 50796120 50796150 MHRA reference: 40632523
  15. Trinity Biotech: Oxalate Rgnt B(591-2) Oxalate Kit 100 Assay(591-D) 46253 MHRA reference: 40644810 2026/008/021/601/069

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

Page summaryUpdate / change
Nonen/a

Section 3: estates, facilities or general products

1.     Product Recall: Simple Kind to Skin Micellar Cleansing Water 200ml, 400ml and 730ml (2608-0103) updated

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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