Published on: Mon 18 May 2020

Face mask recalls, week 20/2020

During the COVID-19 pandemic is it hase become sort of a tradition; the publication of new published face mask recalls. The European Commission (EC) has published this week 4 more recalls for face masks (officialy designated as 'surgical mask' or 'respitory mask'). This week the recalls were alerted by the Croatian, Danish and Luxembourg authorities. 

If you are an economic operator* for these products, product recalls can help you make better products and prevent problems with market surveillance authorities.

See also our post of week 19 here, wk 18 here and wk 17 here. This weeks alerts were submitted by the Danish and Spanish market surveillance authorities.

  1. The first product, a 'Protective respiratory filtration half-face mask of category FFP2 according to EN 149', bears a CE marking but has not been tested and accredited as protective equipment according to European standards. 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 withdrawal of the product from the market (By: Distributor). The product was imported from China (link to recall on Safety Gate). 
  2. The second product, a 'Fabric half-face mask with alleged protection potential against Covid 19', advertises a protective potential against viral particles but its filtering capacity has not been certified by the relevant protective equipment 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 measures to be taken are a stop of sales (By: Importer). The product was imported from China (link to recall on Safety Gate). 
  3. The third product, a 'Fabric respiratory filtration half-face mask with alleged protection potential against Covid 19',  advertises a protective potential against viral particles but its filtering capacity has not been certified by the relevant protective equipment 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 measures to be taken are 'Ban on the marketing of the product and any accompanying measures (By: Importer)'. The product was imported from China (link to recall on Safety Gate). 
  4. The fourth product of this week is a 'Folded respiratory protective half-face filter mask of category FFP2 (EN 149), with nose clip and elastic bands to secure it behind the ears'. The product bears a CE marking but is not certified as protective equipment by a relevant body. Additionally, the particle/filter retention of the material is insufficient (measured value ≤ 68.5 %). 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. The measures to be taken are 'Destruction of the product'. The product was imported from China (link to recall on Safety Gate). 

More information

---

* 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.

 


Share this post via: