The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Device Safety Information alert (DSI/2026/007) advising healthcare professionals and organisations to immediately stop using and supplying several medical devices on the UK market.
The regulator has identified certain products that lack the required UKCA or CE conformity markings and supporting certification mandated under the UK Medical Devices Regulations 2002 and EU Medical Devices Regulation (EU) 2017/745.
The products impacted include devices used in clinical settings for blood collection and infusion, surgical and biopsy procedures, wound management, and skin preparation.
Although no specific product defect, performance failure, or adverse safety signal has been reported, the lack of formal conformity assessment means the regulator cannot ensure the devices meet UK standards for safety, quality, and sterility.
The affected products are:
- VAKU-8 Blood Collection / Infusion / Scalp Vein Set; Hindustan Syringes & Medical Devices Ltd
- Bipson’s Gauze Swab Sterile; Bipson Surgical Private Ltd
- Technocut Scalpel; Niraj Industries Ltd
- Romsons Alco Swabs; Romsons Group Private Ltd
- Medi Grip Adhesive Bandage (Antiseptic); Precision Coatings (P) Ltd
- Bone Marrow Biopsy Needle; Meditech Devices Pvt. Ltd.
Required actions for healthcare teams and distributors
- Quarantine Stock: Immediately cease using or distributing any of the listed devices, isolate remaining inventory, and retain stock pending further instructions from the MHRA.
- Switch to Compliant Items: Source compliant alternative medical devices to maintain operational continuity.
- Notify the MHRA: Report possession or distribution of any affected devices to devices.compliance@mhra.gov.uk quoting reference DSI/2026/007, including details of onward distribution.
- Report Adverse Incidents: Healthcare staff should report any suspected adverse events involving medical devices via the Yellow Card scheme (in England, Wales, and Northern Ireland) or local incident reporting systems.
