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Recall Classifications — Class I · II · III

Health Canada classifies recalls into three classes based on the health risk associated with the deficiency.

Class I — Highest risk​

Definition: A situation in which there is a reasonable probability that the use of a device will cause serious adverse health consequences or death.

Examples:

  • Sterility failure in an implantable or invasive device
  • Critical software error that causes incorrect dosing in an infusion pump
  • Electrical fault in a life-supporting device
  • Contamination of a blood-contact device

Implications:

  • Immediate action required — Health Canada expects rapid initiation of the recall
  • Health Canada publishes a public notice in its Recalls and Safety Alerts database
  • High effectiveness check requirements (typically 100% response expected)
  • Health Canada may issue a public health advisory

Class II — Moderate risk​

Definition: A situation in which the use of a device may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.

Examples:

  • Labelling error that could lead to misuse resulting in moderate harm
  • Software defect that could intermittently produce incorrect results
  • Device component failure that degrades performance below specifications

Implications:

  • Prompt action required
  • Health Canada publishes a public notice
  • Effectiveness checks required

Class III — Low risk​

Definition: A situation in which the use of a device is not likely to cause adverse health consequences.

Examples:

  • Administrative labelling correction (e.g., incorrect lot number format)
  • Cosmetic defect with no safety implications
  • Correction to non-safety-related instructions

Implications:

  • Less urgent
  • Health Canada may or may not publish a public notice
  • Market withdrawal (not a safety recall) may be an option if there is no actual safety risk

Recall class determination​

Health Canada, in consultation with the manufacturer, determines the recall class. The manufacturer's proposed classification in the recall notification is considered but Health Canada makes the final determination.

Legislative source: Medical Devices Regulations, SOR/98-282, s 65; Health Canada Guidance on Medical Device Recalls