The MHRA has told UK healthcare providers to stop using and quarantine a group of medical devices supplied without valid UKCA or CE conformity marking or certification.
The regulator says it has not identified a specific defect or safety event in the listed products. However, because they do not meet the applicable regulatory requirements, their safety, sterility and performance cannot be fully assured.
Affected products may be used in blood collection and infusion, surgery, biopsy, wound care and skin preparation. Organisations should check whether they hold any listed device, stop use and supply, quarantine stock and identify compliant alternatives.
Distributors should stop onward supply, maintain traceability records and inform customers who may have received affected devices. Suspected or actual incidents should be reported through the relevant UK device-safety channel.
