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Health Canada-Initiated Recalls

Section 21.3 orders​

Under Section 21.3 of the Food and Drugs Act, Health Canada may order a person to recall a medical device if:

  • The Minister believes the device presents a serious risk of injury to health
  • The person has failed to voluntarily recall the device

A Section 21.3 order is a legally binding direction — non-compliance can result in prosecution.

When Health Canada acts​

Health Canada typically seeks voluntary compliance first before issuing mandatory orders. Situations that may lead to Health Canada-initiated action:

  • A manufacturer refuses to recall despite evidence of a significant safety deficiency
  • A recall is initiated but not executed effectively (low response rate)
  • A company is unresponsive to Health Canada enquiries about a safety issue
  • Imported devices are seized at the border before the importer initiates a recall

Seizure authority​

Health Canada inspectors have authority to seize medical devices suspected to be non-compliant or unsafe under the Food and Drugs Act.

Public advisories​

Health Canada may issue a public advisory independently of (or in addition to) the manufacturer's Field Safety Notice when:

  • There is an urgent public health risk
  • The affected patient population is broad
  • The manufacturer's communications are considered insufficient

Public advisories are posted on Health Canada's Recalls and Safety Alerts database and distributed through the Canadian Adverse Event Reporting Program (CAARP).

Legislative source: Food and Drugs Act, RSC 1985, c F-27, s 21.3 (orders to recall); s 23 (seizure and detention)