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Face Mask Surgical Disposable

Health risk / other Protective equipment Other types of alerts

Face Mask Surgical Disposable was recalled on 25 December 2020 under EU Safety Gate alert INFO/00180/20. Health risk / other risk reported by Romania. The product bears a CE marking and claims to meet the requirements of a surgical mask but it has not been certified as such by a relevant European body.

Photo of recalled product: Face Mask Surgical Disposable
Alert NumberINFO/00180/20
CategoryProtective equipment
Risk TypeHealth risk / other
Notifying CountryRomania
Country of OriginPeople's Republic of China
Published25 December 2020

Risk Description

The product bears a CE marking and claims to meet the requirements of a surgical mask but it has not been certified as such by a relevant European body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. The product does not comply with the requirements of the Medical Devices Directive and of the relevant European standard EN 14683.

Measures Taken

Type of economic operator to whom the measure(s) were ordered: ImporterCategory of measure(s): Withdrawal of the product from the marketDate of entry into force: 20/11/2020

Product Description

Face mask surgical disposable.

🏥 What Should You Do?

This recall involves a health risk / other hazard related to Face Mask Surgical Disposable.

About this risk

This product poses a health risk that does not fall neatly into a single category. It may involve multiple hazards or an unusual safety concern identified by authorities.

Recommended action

Stop using the product and follow any specific instructions from the recall notice. Contact the manufacturer or your national consumer protection authority for more details.

Who is at risk?

All consumers who have purchased this product.

View on EU Safety Gate →

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