When a Recall (Recolhimento) is Required

BR-unique

Recalls of medical devices in Brazil are called recolhimentos. They are governed by RDC 753/2022 and may be voluntary (initiated by the registration holder) or compulsory (ordered by ANVISA).

A recall (recolhimento) is required when a device on the market presents a risk to patient safety or does not conform to its registered specifications. Triggers include:

• Adverse event investigation revealing a systemic safety issue;
• Discovery of a manufacturing defect or contamination;
• Post-market testing revealing non-conformance; and
• ANVISA or state VISA inspection findings requiring corrective action.

Registration holders should have a recall procedure documented in their quality system that defines triggers, escalation criteria, and responsibilities.

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Official sources

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