The Medicines and Healthcare products Regulatory Agency (MHRA) advised healthcare professionals on 10 August 2026 to stop using and supplying certain medical devices placed on the UK market without the conformity markings required under the UK Medical Devices Regulations 2002 and EU Regulation 2017/745. The affected items include products for blood collection and infusion, surgical and biopsy procedures, wound management and skin preparation.
The MHRA said it had not identified any specific defect, performance, quality or safety signal in the products. It said, however, that because the devices had not undergone the appropriate conformity assessment, there was not enough reassurance that they met UK regulatory requirements or expected standards for quality, safety and sterility. The named products include a VAKU-8 blood collection/infusion set, Bipson gauze swabs, a Technocut scalpel, Romsons Alco swabs, a Medi Grip antiseptic adhesive bandage, a bone marrow biopsy needle and a Meditech Devices product.
Organisations were asked to stop use and supply, quarantine remaining stock and use compliant alternatives, and to notify the MHRA at devices.compliance@mhra.gov.uk, quoting DSI/2026/007, retaining affected devices pending further advice. Distributors were advised to halt further supply and assist with traceability. Healthcare professionals were asked to report suspected or actual adverse incidents through their regional arrangements.


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