Recall Classifications in Brazil
BR-unique
ANVISA classifies recalls into categories based on health risk, determining the scope and urgency of the action:
| Category | Definition |
|---|---|
| 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.