Device safety informationMHRA
Devices supplied without valid UKCA/CE conformity markings or certification safety warning over a safety concern
The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) or with the EU Medical Devices Regulation (EU) 2017/745 (EU MDR).
What to do now
Devices supplied without valid UKCA/CE conformity markings is the subject of an MHRA device safety notice.
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2026/007). Quoted as issued.
Summary
The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) or with the EU Medical Devices Regulation (EU) 2017/745 (EU MDR).
The risk
Summary The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) or with the EU Medical Devices Regulation (EU) 2017/745 (EU MDR). While the MHRA has not identified a specific defect or safety concern associated with these products, they do not meet the regulatory requirements for supply on the UK market, meaning assurance regarding their safety, sterility and performance cannot be fully guaranteed. The affected devices may be used in a variety of clinical settings, including blood collection and infusion, surgical procedures, biopsy procedures, wound management and skin preparation/ disinfection. Advice for Healthcare Professionals:
Advice for healthcare professionals
The MHRA has become aware of a number of medical devices being supplied on the UK market that do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) or with the EU Medical Devices Regulation (EU) 2017/745 (EU MDR). While the MHRA has not identified a specific defect or safety concern associated with these products, they do not meet the regulatory requirements for supply on the UK market, meaning assurance regarding their safety, sterility and performance cannot be fully guaranteed. The affected devices may be used in a variety of clinical settings, including blood collection and infusion, surgical procedures, biopsy procedures, wound management and skin preparation/ disinfection.
review whether your organisation holds, uses or supplies any of the devices listed in this DSI
immediately stop using and supplying any identified product(s) and quarantine all remaining stock
identify and use alternative compliant products
retain affected devices pending further advice from the MHRA
alert the MHRA that you are in possession of an affected device via devices.compliance@mhra.gov.uk quoting the DSI reference number (DSI/2026/007)
providers should ensure all relevant members of staff receive this Device Safety Information (DSI) and that they understand the problem and actions to be taken
report any suspected or actual adverse incidents involving these devices. There are specific reporting arrangements for healthcare professionals to follow in each region
healthcare professionals should report incidents:
in England and Wales to the Yellow Card scheme or via the Yellow Card app
in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
in Northern Ireland to the Yellow Card website in accordance with your organisations medical device policies and procedures
Advice for patients
there is no advice for healthcare professionals to provide to patients regarding this DSI
Open the MHRA notice
Questions
Why has Devices supplied without valid UKCA/CE conformity markings been recalled?
Devices supplied without valid UKCA/CE conformity markings is the subject of an MHRA device safety notice. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.