On 10 August 2026, the Medicines and Healthcare products Regulatory Agency published a device safety intervention telling healthcare professionals and suppliers to stop using and supplying six medical devices that were placed on the UK market without the conformity markings or supporting certification required for legal supply. The notice sits alongside Device Safety Information reference DSI/2026/007. (gov.uk) The regulator stated that it has not identified a specific defect, performance problem, quality failure or safety signal in the products themselves. The issue is regulatory assurance: because the devices have not been through the applicable conformity assessment, the MHRA said it cannot give full assurance on safety, sterility or performance to the standard expected for the UK market. (gov.uk)
According to the MHRA notice, the affected products are the VAKU-8 blood collection, infusion and scalp vein set from Hindustan Syringes & Medical Devices Ltd, Bipson's Gauze Swab Sterile from Bipson Surgical Private Ltd, the Technocut scalpel from Niraj Industries Ltd, Romsons Alco Swabs from Romsons Group Private Ltd, Medi Grip Adhesive Bandage (Antiseptic) from Precision Coatings (P) Ltd, and a bone marrow biopsy needle from Meditech Devices Pvt. Ltd. (gov.uk) These products are used across routine clinical activity, including blood collection, infusion, surgery, biopsy work, wound management and skin preparation. The MHRA classified the communication as device safety information relevant to several specialties, including general practice, general surgery, haematology and oncology, pathology and theatre settings. (gov.uk)
The immediate instruction for providers is operational rather than precautionary guidance alone. Organisations are being asked to check stock holdings and clinical areas, remove any affected devices from use, quarantine remaining units, retain them pending further MHRA advice, and switch to compliant alternatives without delay. (gov.uk) Where affected stock has been received, supplied or distributed, the MHRA says organisations should notify the agency at once and include any known onward distribution, quoting DSI/2026/007. The policy purpose is traceability as well as containment, so procurement, stores and governance teams will need a clear record of where stock has moved. (gov.uk)
The DSI places separate obligations on distributors. They have been told to cease further supply, help with traceability where requested, maintain records of customers supplied with the devices, and contact customers who may have received affected stock. (gov.uk) For NHS trusts, independent hospitals and primary care providers, that means the compliance exercise does not end with pulling items from shelves. Purchasing teams will need to reconcile supplier records against local inventory and confirm that any substitute products have a valid regulatory route to market. This is an inference drawn from the MHRA's traceability and alternative-product instructions, together with its wider guidance on placing devices on the Great Britain market. (gov.uk)
MHRA guidance states that devices placed on the Great Britain market must comply with the Medical Devices Regulations 2002 and complete the relevant conformity assessment before a UKCA mark is affixed. Manufacturers must sign a declaration of conformity, while device classes that require third-party assessment need certification from a UK approved body; separately, valid CE-marked devices remain acceptable in Great Britain within current transitional timelines. (gov.uk) That distinction is central to this case. The agency is not suggesting that all imported or CE-marked devices are problematic; it is acting because the products named in DSI/2026/007 did not have valid conformity markings or the supporting certification needed for lawful supply. A device may therefore appear familiar in clinical use and still fall outside the legal supply framework if the underlying regulatory documentation is missing or invalid. (gov.uk)
For clinicians, the reporting position remains unchanged. The MHRA says suspected or actual adverse incidents involving these devices should be reported through the regional arrangements already in place, including Yellow Card in England, Wales and Northern Ireland and IRIC in Scotland. The DSI also states that there is currently no specific patient-facing advice attached to this alert. (gov.uk) The practical message from the regulator is that the absence of a known defect does not remove the duty to act. In policy terms, this is a market access and assurance case: if markings and supporting certification cannot be verified, providers are expected to treat the stock as non-compliant, quarantine it, and move to devices that can be lawfully supplied and traced. (gov.uk)