ANVISA Recall & Alert Tracker
ANVISA publishes official recall notices (comunicados de recolhimento) and safety alerts (alertas de segurança) for medical devices on its website. This page explains how to access and monitor this information.
Finding ANVISA recalls and safety alerts
ANVISA publishes recall and safety alert information in two locations:
-
ANVISA website — the primary source for official communications:
-
Diário Oficial da União (DOU) — compulsory recalls and regulatory actions are published in the DOU:
Types of ANVISA safety communications
| Type | Description |
|---|---|
| Comunicado de Recolhimento | Official recall notice — voluntary or compulsory |
| Alerta de Segurança | Safety alert — advises healthcare professionals and patients of a safety issue |
| Nota Técnica de Segurança | Technical safety note — provides detailed guidance on a safety issue |
| Medida Cautelar | Emergency precautionary measure — immediate action required |
Monitoring recalls as part of PMS
Registration holders and distributors must monitor ANVISA's recall and safety alert database as part of their post-market surveillance (PMS) programme — both for their own devices and for competitor devices where safety signals may be relevant.
Verify all information against official ANVISA sources before making regulatory decisions.