Face mask recalls, week 21/2020

Introduction

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 6 more recalls for face masks (officialy designated as 'surgical mask' or 'respitory mask'). This week the recalls were alerted by the Belgian and Polish 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 20 here, week 19 here, wk 18 here and wk 17 here.

This weeks alerts were submitted by the Belgian and Polish market surveillance authorities.

1. The first product: an 'Anatomic disposable single use mouth protective mask'. The particle/filter retention of the material is insufficient (measured value ≤ 64 %) and the mask does not properly adapt to the face. 
   - 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 result is a ban on the marketing of the product and any accompanying measures. The product was imported from Mexico (link to recall on Safety Gate). 
   
   
2. The second product is a 'Respiratory protective mask of category KN9'. The product poses the risk: that the particle/filter retention of the material is insufficient (measured value ≤ 93 %) and the mask does not properly adapt to the face.
   - 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 result is recall of the product from end users. The product was imported from China (link to recall on Safety Gate). 
   
   
3. The third product, a Respiratory protective filtration half-face mask of category FFP2 according to EN 149,  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 ≤ 53 %).
   - 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 result is a ban on the marketing of the product and any accompanying measures. The product was imported from China (link to recall on Safety Gate). 
   
   
4. The fourth product is a respiratory protective filtration half-face mask of category FFP2 according to EN 149. The particle/filter retention of the material is insufficient (measured value ≤ 53 %).
   - 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 result is a ban on the marketing of the product and any accompanying measures (link to recall on Safety Gate). 
   
   
5. The next product is (another) respiratory protective filtration half-face mask of category FFP2 according to EN 149. The particle/filter retention of the material is insufficient (measured value ≤ 90 %).
   - 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 ordered are warning consumers of the risks. The country of origin is unknown (link to recall on Safety Gate).
   
   
6. The last face mask recall of this week is a Respiratory protective filtration half-face mask of category FFP2 according to EN 149. The particle/filter retention of the material is insufficient (measured value ≤ 59 %).
   - 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 ordered are warning consumers of the risks. The country of origin is unknown (link to recall on Safety Gate).

More information

• Learn more on legislation filters masks and respitory devices must comply to by downloading the free ProductIP guide on this subject.
• Learn more on where to certify masks here. 

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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.