Healthcare providers, distributors and medical suppliers across the UK are being urged to immediately stop using and supplying six medical devices after the Medicines and Healthcare products Regulatory Agency (MHRA) identified that they were placed on the UK market without the required regulatory conformity markings and certification.
The action follows concerns that the products have not undergone the appropriate conformity assessment process required under the UK Medical Devices Regulations 2002 and the EU Medical Devices Regulation (EU) 2017/745. While the MHRA has stressed that no specific safety, quality or performance defects have been identified, the absence of the necessary regulatory approvals means there is insufficient assurance that the devices meet UK standards for quality, safety and sterility.
The affected products are used across a range of healthcare settings, including blood collection, infusion, surgical procedures, wound care and skin preparation:
- 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.
The MHRA is advising all healthcare organisations, providers, procurement teams and distributors to urgently check stock inventories and clinical settings for any of the affected devices.
Any products identified should be:
- Removed from use immediately
- Withdrawn from supply chains
- Quarantined pending further MHRA advice
- Replaced with compliant alternatives where available
Organisations that have received, supplied or distributed any of the affected devices must notify the MHRA without delay and provide details of any onward distribution where known. Reports should reference DSI/2026/007.
The regulator has emphasised that it has not identified any specific defect, quality issue, performance failure or safety signal associated with the products. However, because the devices have not been subjected to the required conformity assessments, healthcare organisations cannot be assured that they meet the regulatory standards expected for medical devices supplied within the UK market.
This means that despite the absence of identified faults, continued use of the products could expose organisations to compliance and governance risks.
Distributors have also been instructed to stop further supply of the devices and support any traceability investigations requested by the regulator.
The MHRA is seeking to establish the extent of distribution across the UK healthcare system and is asking organisations to retain affected products while further investigations continue.
Healthcare professionals who believe an adverse incident may have occurred involving any of the listed devices should report it through the established reporting systems in their respective UK nations.
The regulator has also reminded organisations to ensure medical devices purchased and deployed within their services comply with current UK medical device regulations and carry the appropriate certification and conformity markings.
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