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When a Recall is Required

Definition​

A recall is any action taken by a manufacturer, importer, or distributor to remove a medical device from the market or correct a deficiency in a distributed device, where the device:

  • May cause serious adverse health consequences, or
  • Has a deficiency that could cause serious adverse health consequences if not corrected

Recall triggers​

A recall may be triggered by:

  • Mandatory problem report investigations revealing a systematic device deficiency
  • Post-market surveillance data identifying a safety signal
  • Complaint analysis revealing a pattern of failures
  • Third-party or regulatory reports of similar devices (in Canada or other jurisdictions)
  • Internal quality testing failures revealing out-of-specification product already distributed
  • Supplier notification of a component defect
  • Health Canada direction following a compliance inspection or investigation

Voluntary vs. mandated recalls​

Most recalls in Canada are voluntary — initiated by the manufacturer or importer before Health Canada orders one. Voluntary recalls demonstrate proactive safety culture and are viewed more favourably by Health Canada than mandated recalls.

Health Canada can mandate a recall under Section 21.3 of the Food and Drugs Act if the manufacturer or importer fails to act voluntarily when a safety issue has been identified.

Notifying Health Canada​

Manufacturers and importers must notify Health Canada before initiating a recall, or as soon as possible after becoming aware that a recall is necessary. The notification must include:

  • Device identification and affected lot numbers
  • Description of the deficiency
  • Health risk assessment
  • Proposed recall strategy

Not all corrective actions are recalls​

A Field Safety Corrective Action (FSCA) is broader than a recall. Not all FSCAs involve retrieving devices — some involve modifications, software updates, or additional warnings communicated to users via a Field Safety Notice. See Field Safety Corrective Actions.

Legislative source: Medical Devices Regulations, SOR/98-282, s 65; Food and Drugs Act, s 21.3