Recall Health FAQs

Recall Health is a digital platform that provides real-time communication, visibility and management of required actions in the event of product recalls for therapeutic goods.

• Real-time communication

• Ensures TGA compliance

• Electronic and standardised process

• Improved visibility throughout recall process

• Risk management and brand protection

Recall Health is used for products that are regulated by the TGA. For food products regulated by FSANZ and ACCC, you should use the Recall portal.

• Sponsors

• Wholesalers

• Purchasing authorities

• Public and private hospitals

• Pathology

• Biomedical engineering

• Hospital & community pharmacies

• Aged care and more

The Recall Health platform allows for PRAC-defined recall and non-recall notices, as well as industry-specific communications of:

• Jurisdiction initiated notice

• Recall raised offline

• Withdrawal raised offline

Where products or circumstances fit into the category of significant risk (refer to TGA Recalls for criteria), sponsors should follow the steps to enact an immediate recall.

Yes. Recall Health uses the Secure Sockets Layer (SSL) security protocol, which runs in the background and is invoked when required. Each user is required to accept the
Recall Terms and Conditions.

The Recall Health platform was developed collaboratively as an industry-governed workflow tool that includes the facilitation of compliance to the Procedure for Recall Alerts and Corrections (PRAC). Participants in the scoping and development process included Industry Bodies, Manufacturers and product sponsors, Buyers and health providers, the Therapeutic Goods Administration (TGA) and the Australian Digital Health Agency (previously known as National eHealth transition Authority).

Once you submit your registration, it will be processed by the following business day. Once this is complete you can issue a recall or withdrawal notice.
In cases of emergency, the Recall Health Support Team can assist you with a same day service allowing you to complete a recall or withdrawal notification, on the day you subscribe.

You can include non-subscribed recipients in your recall notification using email or fax. Email recipients will receive an email containing a summary of the notice, as well as a link that allows them to download a copy of the full notice. The link also serves as an acknowledgment of their receipt of the notice, which is automatically reported to the initiator.
Fax recipients will receive the notice and any attachments in full.

Organisations may not plan on recalling or withdrawing a product. However, despite best due-diligence, product recalls or trade withdrawals can occur. Recall Health includes a mock recall function to assist subscribers in the training of their staff on the recall process.

To register your organisation for Recall Health, visit the GS1 Australia website where you can use the online
registration form.