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ANVISA-Initiated Mandatory Recall

When ANVISA determines that a device on the market presents an unacceptable risk to public health and the registration holder has not voluntarily initiated a recall, ANVISA may:

  1. Issue a Medida Cautelar (precautionary measure) — immediately suspending the sale, distribution and use of the device;
  2. Order a Recolhimento Compulsório (compulsory recall) — the registration holder must remove the device from the market;
  3. Initiate an Interdição (seizure) — physical apprehension of devices by VISA; and/or
  4. Initiate Cancelamento de Registro (registration cancellation) — permanently revoking the device's marketing authorisation.

Failure to comply with a compulsory recall or ANVISA enforcement action is a serious infraction under Lei 6.437/1977 and may result in substantial fines.

Official sources

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