Recall Classifications & Levels
Overview
Under the PRAC (effective March 2025), market actions are classified into three classes based on the level of risk posed by the device issue. The class determines the urgency of the corrective action, the level of detail required in the recall strategy, and the depth of distribution to which the action must reach. Sponsors must assess the appropriate class of market action in consultation with the TGA.
Class I — Critical Risk
Definition: Situations where use of the device could cause serious health consequences or death, or where there is a reasonable probability that the device will cause a serious adverse health consequence.
Examples:
- A pacemaker with a software defect that could cause inappropriate shock delivery
- An IVD with a systematic calibration error causing incorrect results that could lead to delayed diagnosis of a life-threatening condition
- A sterile device found to have compromised sterility in a manner that could cause serious infection
Required action:
- Immediate notification to TGA
- Urgent communication to all affected customers and healthcare facilities
- Broad distribution reach — may extend to patient level for implantable or critical-use devices
- Public recall notice published by TGA on the DRAC database
- Recall of product from all levels of the supply chain where possible
Class II — Moderate Risk
Definition: Situations where use of the device may cause temporary adverse health consequences, or where there is a remote probability of serious injury but the risk of serious harm is not immediate.
Examples:
- A blood glucose monitor with a systematic positive bias causing mildly elevated readings
- A surgical instrument with a labelling error regarding a contraindication
- Premature battery depletion in an active device outside the expected failure rate
Required action:
- Prompt notification to TGA and affected customers
- Corrective action appropriate to the level of risk
- TGA publishes market action notice
Class III — Low Risk
Definition: Situations where the device issue is unlikely to cause injury or adverse health consequences. Often involves cosmetic defects, minor labelling issues, or non-compliance that does not affect safety or performance.
Examples:
- A labelling error in non-critical product information (e.g., incorrect storage temperature stated as 15–25°C instead of 15–30°C where the device was adequately stored)
- A minor deviation from packaging specifications with no effect on sterile barrier or device function
Required action:
- Notification to TGA
- Corrective action at the trade level only in many cases
- Lower urgency — planned correction may be acceptable
Distribution Levels
The depth of recall (how far down the supply chain the action reaches) depends on the class of market action and the nature of the device:
| Level | Reaches |
|---|---|
| Trade level | Sponsors, distributors, and wholesalers only |
| Hospital/facility level | Healthcare facilities, clinics |
| Patient level | Individual patients who have received the device (typically for implants or direct-to-consumer devices) |
Class I actions for implantable devices will typically require patient-level recall. The TGA determines the required distribution level as part of approving the recall strategy.
The DRAC — Public Database
The Database for Recalls, Product Alerts and Product Corrections (DRAC) — formerly SARA — is the publicly accessible database where the TGA publishes all market action notices. Sponsors, healthcare facilities, and the public can search DRAC to find current and historical market actions.