When a Recall is Required
Overview
From 5 March 2025, the Procedure for Recalls, Product Alerts and Product Corrections (PRAC) is the official framework for managing recalls and other market actions in Australia. The PRAC replaced the previous Uniform Recall Procedure for Therapeutic Goods (URPTG). It introduces simplified terminology, reduces the procedural steps from 10 to 5, and uses the unified term "market action" for all types of corrective actions. Sponsors should ensure their recall procedures and SOPs are updated to reflect the PRAC.
What Triggers a Market Action?
A market action is required when a sponsor or manufacturer becomes aware that a device currently supplied in Australia:
- Does not meet the Essential Principles — the device has a safety or performance deficiency
- Could cause or has caused patient harm — including harm identified through adverse event reports, complaints, or post-market surveillance
- Has a labelling or information deficiency — incorrect or missing information that could affect safe use
- Is subject to an overseas market action — if a recall or field safety corrective action is initiated overseas for a device supplied in Australia, a market action must also be initiated in Australia
A market action must also be initiated when the TGA directs the sponsor to take action — see TGA-Initiated Actions.
The Four Types of Market Actions Under PRAC
The PRAC replaces the eight previous action categories with four simplified types:
| Market Action | Description |
|---|---|
| Recall | Removal of a device from the market (from supply chain and/or from use by patients) for safety reasons |
| Product Alert | Public notification of a potential issue without necessarily removing the product from market — used where the product can continue to be used safely with additional information or precautions |
| Product Correction | Corrective actions for devices already distributed — such as software updates, labelling corrections, or modified instructions — without removing the device from market |
| Quarantine | Temporary hold on supply or use of a device pending a safety assessment |
Three Classes of Market Action (by Risk)
The PRAC classifies market actions by risk level — note that these "classes" are different from device classification:
| Class | Risk Level | Description |
|---|---|---|
| Class I | Critical | Situations requiring immediate action — the device could cause serious health consequences or death |
| Class II | Moderate | Urgent corrective action required — the device may cause temporary adverse health consequences or there is a remote probability of serious injury |
| Class III | Low | Actions unlikely to cause injury — minor deficiencies or cosmetic issues |
The class of market action determines the urgency and extent of the corrective action required.
The Obligation to Notify the TGA Promptly
When a sponsor becomes aware of a situation that may require a market action, they must notify the TGA as soon as possible. For Class I situations (critical safety issues), this means immediate notification. The sponsor must not begin communicating with customers or initiating product removal until the TGA has reviewed and approved the recall strategy — except in the most serious situations where an imminent threat to patient safety means immediate action is necessary before TGA approval can be obtained.
Notifying the TGA late — or failing to notify at all — is a serious breach of ARTG conditions.
Overseas Market Actions
Any recall, field safety corrective action, or other remedial action taken overseas for a device that has been supplied in Australia must be reported to the TGA Recalls team, even if the underlying adverse event does not require IRIS reporting. Australia is not automatically included in overseas recall actions — the sponsor must assess whether the Australian-supplied devices are affected and initiate an Australian market action if they are.
Contact the TGA Recalls team: recalls@tga.gov.au