Alerts

Stryker is conducting a Critical Product Correction of Pad-Paks used with the HeartSine samaritan Public Access Defibrillator (PAD), with an expiry date range between 17 April 2025 to 01 August 2029.

Bliss Baby is recalling all batches of ARTG 351147 - Flatus tube, single-use - Lufti Colic Reliever, due to insufficient evidence provided to the TGA to support its safe use.

Boston Scientific have advised that subsets of ACCOLADE and VISIONIST pacemakers have an increased risk of permanently entering Safety Mode which has limited functionality.

There is a potential for insulin leakage with the Accu-Chek Spirit 3.15 ml cartridge system due to a manufacturing problem.

Be alert to the issue of unexpected shut down of the A30 and A40 series bi-level positive airway pressure (BiPAP) devices. This can cause interruptions and loss of therapy for patients.

Be alert about a higher risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system. Read this if you're a patient, carer or health care provider.

The companies supplying Fanttest COVID-19 test kits were made aware of the potential for variability in the way the control line appears (ie a weak/faint/pale control line) when strong COVID-19 positive results are obtained.

If you have an implanted SMR MB L1 Liner you may be at higher risk of requiring revision surgery.

Testing indicates the presence of Ralstonia pickettii in saline products manufactured by Legency Remedies Private. As a precaution, Aerowash Eyewash and Wound Irrigation ampoules are being recalled in Australia.

Medtronic Australasia Pty Ltd is alerting patients who have an implanted SynchroMed II Pump that it may not function properly after they undergo a Magnetic Resonance Imaging (MRI) procedure.

We're continuing to investigate and take action on the potential contamination of some saline products with Ralstonia pickettii. Read about the latest round of product recalls.

Testing indicates the presence of Ralstonia pickettii in additional saline products manufactured at Legency Remedies Private. All batches of these products are now being recalled from the Australian market.

We're continuing to monitor adverse events from masks that have magnets interacting with implantable medical devices. Find out how we're working with companies supplying these devices in Australia and international regulators.

Interpharma Pty Ltd is recalling all batches of Sodium Chloride 0.9% 30mL ampoules due to potential contamination with Ralstonia pickettii. You can return them for a refund.

We're continuing to investigate and take action about the potential contamination of some saline products with Ralstonia pickettii. Read about a product recall and quarantines.

We're aware of Ralstonia pickettii cases in patients across Australia and are working closely with health departments to investigate the possible role of therapeutic goods.

ResMed Pty Ltd is updating the safety information and warnings for their masks that have magnets.

If you use a glucose monitoring device or system, it may be affected by the Optus mobile and WiFi outage. Be alert and report any concerns to your health care professional.

Find out about a software problem with the SmartDrive MX2+ App, for the PushTracker E2 and E3 wearable watches, causing safety issues for operating manual wheelchairs.

Be alert to an issue affecting all units of the Scandinavian Total Ankle Replacement (STAR) Ankle Prosthesis supplied in the Australian market.

Medtronic Australasia is informing customers about the serious risk of valve infolding for EvolutePRO+ 34mm Transcatheter Aortic Valve (TAV), item code - EVPROPLUS-34US.

Users may experience extended periods of signal loss and during this time they won’t receive high or low glucose alarms.

Philips Respironics (the manufacturer) detected two problems with corrected Trilogy 100 ventilators

Zimmer Biomet, in consultation with the TGA, is issuing an Implant Hazard Alert for the NexGen Stemmed Cemented Option Tibial Component.

Safety advisory - Compatibility of tubing connectors and medical gas sources