The affected devices include products used in clinical settings for blood collection and infusion, surgical and biopsy procedures, wound management and skin preparation.

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. 

Although the MHRA has not identified any specific defect, performance issue, quality issue, or safety signal with the products, because they have not undergone the appropriate conformity assessment for supply in the UK, there is not enough reassurance they meet UK regulatory requirements or the expected standards for quality, safety and sterility.

Organisations are advised to 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.