MHRA advises quarantine of medical devices supplied without appropriate conformity markings
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 Medicines and Healthcare products Regulatory Agency (MHRA) is advising healthcare professionals to stop using and supplying certain medical devices that have been supplied on to the UK market without the appropriate conformity markings required under the UK Medical Devices Regulations 2002 and under the EU Medical Devices Regulation (EU) 2017/745.
The affected devices include products used in clinical settings for blood collection and infusion, surgical and biopsy procedures, wound management, and skin preparation. The devices do not have the appropriate conformity markings and supporting certification required for legal supply on the UK market.
The MHRA has not identified any specific defect, performance issue, quality issue, or safety signal with the products. However, because the devices have not undergone the appropriate conformity assessment for supply in the UK, there is not enough reassurance that they meet UK regulatory requirements or the expected standards for quality, safety, and sterility.
The affected products are:
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VAKU-8 Blood Collection / Infusion / Scalp Vein Set; Hindustan Syringes & Medical Devices Ltd
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Bipson’s Gauze Swab Sterile; Bipson Surgical Private Ltd
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Technocut Scalpel; Niraj Industries Ltd
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Romsons Alco Swabs; Romsons Group Private Ltd
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Medi Grip Adhesive Bandage (Antiseptic); Precision Coatings (P) Ltd
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Bone Marrow Biopsy Needle; Meditech Devices Pvt. Ltd.
Individuals and organisations should check whether they have any of the affected devices in use or available for supply. If they do, they should immediately stop using and supplying them, quarantine any remaining stock, and use compliant alternatives. Images of the affected products and further information can be found in the Device Safety Information (DSI). For information on identifying compliant medical devices and using them safely, visit the MHRA’s medical device guidance for patients and users.
Organisations should notify the MHRA immediately via devices.compliance@mhra.gov.uk if they think they have received, supplied or distributed any affected devices, and provide details of any onward distribution where known, quoting the DSI reference number (DSI/2026/007). Organisations should retain affected devices pending further advice from the MHRA.
Distributors have been advised to cease further supply of the affected devices and notify the MHRA if they have received, supplied or distributed any of the products. They should also assist with traceability activities where requested.
Healthcare professionals have been advised to report any suspected or actual adverse incidents involving these devices through the appropriate reporting arrangements for their region. Guidance on how to tell if a medical device is compliant Further information on how to tell if your device conforms to UK safety regulations can be found through
Notes to editors:
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The manufacturers’ field safety notices (FSN) issued to its customers are available here: https://www.gov.uk/drug-device-alerts
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The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
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Healthcare organisations in possession of affected devices should notify the Medicines and Healthcare products Regulatory Agency (MHRA) via devices.compliance@mhra.gov.uk, quoting DSI reference DSI/2026/007.