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Recall Classifications in Brazil

BR-unique

ANVISA classifies recalls into categories based on health risk, determining the scope and urgency of the action:

CategoryDefinition
Urgente (Urgent)Situations presenting immediate serious risk to life or health — must be actioned within 24 hours
Voluntário (Voluntary)Registration holder initiates recall; ANVISA notified; device removed from market and from patients where applicable
Compulsório (Compulsory)ANVISA orders the recall; failure to comply may result in interdição or cancelamento de registro

All recalls must be notified to ANVISA via Peticionamento Eletrônico and communicated to distributors and healthcare facilities using a Field Safety Notice (Comunicado de Segurança).

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.

"Notification timelines: Urgent recalls must be reported to ANVISA within 24 hours of decision to recall. Voluntary recalls should be notified to ANVISA simultaneously with or before market withdrawal. Compulsory recalls must be actioned within the timeframe specified by ANVISA's order."