New published face mask recalls

Introduction

The European Commission (EC) has published this week two more recalls for face masks (officialy designated as 'surgical mask' or 'respitory mask'). See also the ProductIP guidance on surgical masks and respirory masks (link).

If you are an economic operator* for these products, product recalls can help you make better products and prevent problems with market surveillance authorities.  The EC published last week 2 more cross-border face masks products that pose a serious risk (link to the products on Safety Gate). The alerts were submitted by the Belgian and Danish market surveillance authorities.

1. The first product bears a CE marking but is not certified as protective equipment by the relevant body. Consequently, the product might not fulfil the health and safety requirements and properly protect when combined with additional measures. The product does not comply with the Personal Protective Equipment Regulation. The result is that the product is banned from marketing and any accompanying measures. The product was imported from China. 

2. The second products particle/filter retention of the material is insufficient (measured value ≤ 62 %). Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. The product does not comply with the Personal Protective Equipment Regulation and the relevant European standard EN 149. Because the product has already reached end users, a recall is ordered from end users. This product was also imported from China. 

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* Economic operator means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation;