Unsafe Particle Filter Masks Recalled in the EU

Particle filter facepieces recalled in the EU after market surveillance finds they fail to conform to efficacy and safety requirements.
( | Press Release | 2020-08-03 16:58:35 )
The European Union (EU) has recently recalled several particle filter masks for non-compliance via its Rapid Alert System for dangerous non-food products (RAPEX).

Market surveillance performed by EU Member States has found that these masks failed to conform to requirements in:
• Regulation (EU) 2016/425 – Personal Protective Equipment (PPE)
• EN 149 – harmonized standard for respiratory protective devices

Non-conformities included:
• Insufficient particle filter retention to match claims
• Uncertified products bearing the CE mark
• Face masks claimed to protect against viral particles, but their filtering capacity was uncertified and their use as biocidal products was unauthorized

Filtering facepieces (FFP or face masks) should protect the wearer from inhaling airborne liquid and solid particles.

Non-conforming products should be:
• Rejected for importation
• Withdrawn from the market and recalls
• Temporarily banned
• Marked with appropriate warnings
• Banned from being marketed in the EU

RAPEX provides EU citizens and businesses with information about products that pose a serious risk to their health and which fail to meet EU legislative requirements.

SGS Medical PPE Services
SGS offers a full range of services to help manufacturers and suppliers of medical PPE deliver high quality, safe, and compliant products to markets around the world. Learn more about SGS Medical PPE Services. []

SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full EU RAPEX Recall Particle Filter Masks from Markets SafeGuardS. []

Subscribe here,, to receive SGS SafeGuardS direct to your inbox.

For further information contact:

Louann Spirito
Consumer and Retail — Softlines
US & Canada Softlines Business Head
Tel: +1 973 461 7919
LinkedIn: sgs-consumer-goods-&-retail

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

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Ben Christie

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