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Medicine Recalls

50 recalls from tga.gov.au

Medicines, medical devices, and therapeutic goods recalled by the TGA.

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TGA-558493

Flixotide and Pavtide Accuhalers

These Accuhalers each contain a dry powder respiratory product for 60 doses. Each dose is delivered via a patient-activated lever (see Figure 1). The Accuhaler has been designed to automatically reset for the next dose when the patient rotates the Accuhaler clockwise following use (see Figure 2). Figure 1: Accuhaler before use.Figure 2: Accuhaler opened with lever in correct starting position. This is an unaffected product.Figure 3: Accuhaler opened with lever in incorrect starting position. This is an impacted product. GSK identified that a small number of Accuhalers may not automatically reload following the clockwise rotation (see Figure 3). The Accuhaler will function normally for several doses (anywhere between 20-59 doses) and may then stop working.

Product correction

15 Apr 2026

TGA-556105

Medik8 Physical Sunscreen SPF50+ 60mL, 60mL Professional and 15mL

AC Newco Pty Ltd (Advanced Cosmeceuticals), on behalf of Medik8, is recalling all unexpired batches of Medik8 Physical Sunscreen SPF50+ 60mL, 60mL Professional, & 15mL due to the product being unlikely to meet its labelled Sun Protection Factor (SPF) rating.

Medicine

1 Apr 2026

TGA-556070

ACCOLADE single chamber (SR), dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps)

Boston Scientific is conducting a Product correction and Product alert for ACCOLADE and VISIONIST pacemakers.

Product correction

1 Apr 2026

TGA-554732

TRUE METRIX® Blood Glucose Monitoring Systems

The system displays an E-5 error code for a very high blood glucose event (>33.3mmol/L) or when there is a test strip error. The current device instructions do not clearly advise users to seek urgent medical attention.

Medicine

12 Mar 2026

TGA-554270

Rifton TRAM and E-Pacer patient transfer and gait training devices

The TRAM and E-Pacer devices use a body support system that secures the user with straps and buckles. Some metal parts connected to the straps may have sharper edges than intended. Over time, this could cause the strap to wear or fray, which may lead to the strap breaking. What is the risk? If a strap breaks, it could lead to a fall from the device and injury. It is possible that if the strap broke during transfer, the injuries could be serious or life threatening.

Product correction

12 Mar 2026

TGA-550349

Comvita MediHoney Antibacterial Wound Gel 25g & 50g

The packaging may not be sealed properly, which can make the product non‑sterile or cause it to leak. Identified problems include an incompletely sealed foil liner and a folded tube seal that can leave a small gap.

Medicine

26 Feb 2026

TGA-550005

H3 Hintermann Ankle Replacement System

The TGA has concerns about an increased risk of revision as shown in the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data when compared to other fixed and mobile bearing systems. The affected devices from the H3 Hintermann Ankle Replacement System include: ARTG number 289319: Actis Medical Pty Ltd - Ankle prosthesis bearingARTG number 289321: Actis Medical Pty Ltd - Coated ankle talus prosthesis andARTG number 289424: Actis Medical Pty Ltd - Coated ankle tibia prosthesis

Medicine

12 Feb 2026

TGA-549689

Banana Boat Baby Zinc Sunscreen Lotion SPF 50+ and Hawaiian Tropic Mineral Zinc Sunscreen Lotion SPF 50+

The product may appear to have an uneven texture and visible water separating out of the product. If this happens, the ingredients are no longer properly mixed.

Medicine

3 Feb 2026

TGA-549688

Solar Screen Mineral Zinc Hydrating Face and Body Sunscreen Lotion SPF50+

The product may appear to have an uneven texture and visible water separating out of the product. If this happens, the ingredients are no longer properly mixed.

Medicine

3 Feb 2026

TGA-549519

BeneHeart C Series AED: Non-rechargeable public automated external defibrillator

Wi-Fi/Network configurations and battery life When the equipment is configured with Wi-Fi/cellular turned on, it automatically sends self-test reports by default, which consume extra battery power. In some network configurations, this could lead to a shortened battery life. Electrode pads in-position detection The device automatically checks that new electrode pads have been attached after use, before shutdown. If new electrode pads aren’t connected, the status light on the device will flash red. The manual has been updated to make this information clearer. What is the risk? A low battery may cause the device to fail to power on leading to delayed therapy. If new electrode pads aren’t connected after use, this may also lead to a delay, as it must be resolved before delivering therapy. This may impact the effectiveness of resuscitation efforts.

Product correction

29 Jan 2026

TGA-546534

Anko Small and Large Gel Paks

The products have been found to contain ethylene glycol, which is highly toxic. If the packaging becomes damaged, ethylene glycol could leak out. If swallowed, ethylene glycol can cause irreversible injuries or death.

Medicine

9 Jan 2026

TGA-546016

CellAED: Non-rechargeable public automated external defibrillator

The company which has supplied the CellAED devices, RRR Manufacturing Pty Ltd, has gone into liquidation. The liquidators for RRR Manufacturing, are conducting a Critical Recall for all lots of the CellAED device. As the company has entered liquidation, they can no longer support products in the market. Without ongoing support such as maintenance, servicing and handling of faults there is an increased risk of safety or performance problems, meaning the device may not work as intended in an emergency. ARTG NumberProduct nameAffected lot numbers375339CellAED - Non-rechargeable public automated external defibrillatorAll

Recall

19 Dec 2025

TGA-545869

Key Sun Kids Travel Sickness Homeopathic Product

Following a customer complaint, a piece of small metal wire has been identified in one lozenge. The wire likely became stuck in the lozenge during manufacturing. What is the risk? If a small metal wire is present, this could result in a child cutting their mouth. If any pieces of metal are swallowed by a child, this may result in damage to the digestive tract and risk of choking.

Medicine

16 Dec 2025

TGA-537309

Cancer Council Sunscreen Clear Zinc Kids SPF50+ 110g

The product may appear to have an uneven texture and visible water separating out of the product. If this happens, the ingredients are no longer properly mixed. Image1: Cancer Council Sunscreen Clear Zinc Kids SPF50+ 110g Product NameARTGAffected batch numbersExpiry DatesCancer Council Sunscreen Clear Zinc Kids SPF50+ 110gAUST L 4305341143730August 20271141313June 20271146857November 2026

Medicine

4 Dec 2025

TGA-524359

Bondi Sands Zinc Mineral Broad Spectrum UVA & UVB Protection Sunscreen SPF 50+ Face and Body Lotions

The products may appear to have an uneven texture and visible water separating out of the product. If this happens, the ingredients are no longer properly mixed. This could affect the SPF rating and overall performance of the sunscreens which may cause inadequate sun protection.

Medicine

14 Nov 2025

TGA-520153

Mylife CamAPS FX app

Product correction: Ypsomed Australia is reminding users to ensure they use a compatible smart device and operating system (OS) when using the Mylife CamAPS FX app.

Medicine

29 Oct 2025

TGA-520122

Henry Blooms Infant Liquid D3 & K2 with Probiotic, Pack size: 9.75 mL

Phytologic Holdings Pty Ltd is recalling one batch of Henry Blooms Infant Liquid D3 & K2 with Probiotic due to a dosing syringe error.

Medicine

22 Oct 2025

TGA-519340

Multiple sunscreens recall: Lower than claimed SPF levels

Consumers are advised that several sunscreen products are being recalled by sponsors. This follows preliminary testing evidence indicating that the SPF levels of their products may be lower than what is claimed on their labels.

Medicine

25 Sept 2025

TGA-515170

Pad-Pak for HeartSine samaritan Public Access Defibrillator (PAD)

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.

Medicine

18 Sept 2025

TGA-514853

ACCOLADE single chamber (SR), dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps)

Product correction and Product alert. This update includes new information regarding the software correction, actions for healthcare professionals and inclusion of the single chamber (SR) pacemaker.

Medicine

10 Sept 2025

TGA-513941

Ultra Violette Lean Screen SPF 50+ sunscreen

Grace & Fire Pty Ltd (trading as Ultra Violette) is recalling all batches of Ultra Violette Lean Screen SPF 50+ due to inconsistency in the SPF level of the product.

Medicine

21 Aug 2025

TGA-513781

Living Healthy High Strength Gummies

Star Combo Australia Pty Ltd is recalling multiple batches of four Living Healthy High Strength Gummies products due to non-compliant labelling.

Medicine

19 Aug 2025

TGA-513616

t:slim X2 Insulin Pump

Product Alert: Australasian Medical & Scientific Ltd (AMSL), the sponsor of the t:slim X2 insulin pump, has identified that certain versions of the device have a wiring problem with the speaker.

Medicine

17 Aug 2025

TGA-510258

Invacare Birdie Lifter and Compact Lifter

Invacare Australia is updating the Instructions for Use (IFU) of the Birdie Lifter and Compact Lifter. Users need to be aware of the correct position for the carabiner and the correct attachment of the hanger bar.

Medicine

5 Aug 2025

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