Snuggle Hot Water bottles with cover (assorted) (updated)
The hot water bottles do not have the required safety warning permanently marked on them according to the mandatory standard for hot water bottles.
AUSTRALIAN RECALL CATEGORY
Pharmacy and medical products recalls.
227 archived Australian notices, each linked to its official Product Safety Australia source. The page updates automatically when new notices arrive.
Showing notices 1–48 of 227.
IGP Sports HR40 heart rate monitor
The products were sold without the warning information that is required for products containing button/coin batteries.
500ml Essential Oil Distillation Kit
The mesh plate the flask sits on may contain asbestos. There is a risk of exposure to asbestos fibres when using this product.
Mon Chateau Comfort Gel Mat
The corners of some mats may lift up or curl, creating a trip hazard.
UEBE Domotherm rapid REF0830
The product does not comply with the mandatory safety standard for products containing button/coin batteries . The packaging does not display the required warning label and does not display treatment advice in case of ingestion.
Shred Maxx, Shred Maxx Male, Shred Maxx Super Strength, Glow Maxx, Cli Maxx, X Maxx and GMax supplement capsules
These products were supplied within Australia for therapeutic use, without being registered on the Australian Register of Therapeutic Goods (ARTG). These products have not been assessed as required, so their safety and efficacy are unknown. For example, Glow Maxx is noted on the label to contain 1000 micrograms (mcg) of Vitamin D per capsule (per day). Medicines in Australia require a prescription if they contain more than 25 micrograms of Vitamin D per recommended daily dose. 1000 micrograms per day is 40 times this amount and, after prolonged use, could result in toxic effects such as vomiting and diarrhoea.
Fu Gui Ba Wei Tang a.k.a. Rehmannia Eight Vitality Formula & Nuan Gong Cheng Yun Fang a.k.a. Motherhood 1 Formula
These two products contain fennel as an active ingredient. The label on the bottle does not include mandatory wording required for pregnancy and children warning statements.
Young Living ComforCleanse laxatives
ComforCleanse contains an extract from Foeniculum vulgare (fennel). The label on the bottle does not include mandatory wording required for pregnancy and children warning statements.
Accu-Chek Solo Cannula Assembly & Pump Holder and Accu-Chek Solo Supply Kit
Insulin leakage has occurred with the Accu-Chek Solo Cannula Assembly and Pump Holder. If the insulin leakage is not immediately noticed when using the Accu-Chek Solo system this could potentially lead to an under-delivery of insulin.
BiPAP A40, DreamStation, BiPAP A30, BiPAP Auto System One 60 Series, BiPAP AVAPS C Series, BiPAP A40 Pro, Trilogy Evo, REMstar, SIMPLYGO and Elegance devices
The power cord supplied in affected products does not comply with requirements in the Medical electrical equipment standard IEC60601-1.
Aspire Superlite Adjustable Seat Walker
The nut securing the frame’s cross brace in place may become loose over time, leading to the frame becoming unstable.
Detox + Debloat
Detox + Debloat tablets contains an extract from Foeniculum vulgare (fennel seeds). The bottle does not have required pregnancy and children warning statements on the label.
Vicks VapoRub Xtra Strong 100g
Some 100g jars of Vicks VapoRub Xtra Strong in batch number 222605 have been incorrectly labelled as Vicks VapoRub.
DreamWear Full Face Mask, DreamWisp Nasal Mask with Over the Nose Cushion, Wisp Nasal Masks and Wisp Youth Nasal Masks, Amara View Minimal Contact Full-Face Mask and Therapy Mask 3100 NC/SP
The affected masks contain magnets which can potentially affect the functioning of implanted medical devices such as metal splinters in the eyes, brain shunts, aneurysm clips, pacemakers, implantable cardioverter defibrillators, defibrillators, VP shunts, and neurostimulators used in and around the neck or any implanted medical device impacted by magnetic fields. Philips Respironics is updating the existing contraindications and warnings on the Instructions For Use (IFU) to strengthen the current labelling and warnings related to magnets.
Sanjin Watermelon Frost Insufflation
The instructional leaflet enclosed with the bottle contains diagrams showing how to use the product safely. One diagram is shown out of order and with no context, this may result in users incorrectly removing the dosing component from the bottle and pouring the powder out unrestricted.
Omnipod DASH Personal Diabetes Manager (PDM)
The product's battery pack may swell, leak fluid or overheat and could catch on fire.
Dasatinib Dr. Reddy's dasatinib 50 mg film coated tablet blister pack and Dasatinib Dr. Reddy's dasatinib 100 mg film coated tablet blister pack
The tablet may not dissolve properly and this can result in incomplete release of the medicine.
BiPAP A40 Ventilator
Certain devices were built with motor assemblies that may contain non-conforming plastic material.
Lucas’ Papaw Ointment 15g, 75g, 200g
The recall is due to microbial ( Aspergillus tubingensis, Sordaria humana, Penicillium paneum and Paenibacillus glucanolyticu s) contamination.
All MiniMed 640G, 670G, 700, 770G, and 780G Insulin Pumps
The gold battery cap contact may fall off when the user is charging the battery. If the contact falls off, the 'Insert battery' alarm will not clear automatically when the user inserts a new AA battery as the circuit is not complete. This will result in the alarm escalating to a siren and then the pump will shut down and will not power up.
t:slim X2 Insulin Pump
The insulin pump may experience software issues which may disrupt insulin delivery.
Kynd Stress Relief Tablets 30's
Reports of allergic reaction.
ABS6090 AEROBURN PE Burn Sheets, 60 cm x 90 cm
The seals on some of the product may become damaged or broken when handled. If the seal on the pouch opens before use, the dressing may lose its microbiological barrier and become non-sterile.
Trustcare Outdoor Rollators - Trustcare Let's Go Out
The backrest of outdoor rollators may break. The current version of the products Information For Use does not contain any warning to ensure correct use and maintenance of the product.
Havyco Vy & Tea 45g
The product contains the undeclared substances phenolphthalein and sibutramine. The products were supplied without an active Australian Registry for Therapeutic Goods (ARTG) registration.
EleCare, Similac and Alimentum Infant Formula 400g
The recall is due to potential microbial contamination ( Cronobacter and Salmonella ).
Flordis Ellura Capsules
Batch N0121301 of the hard capsule shells contain ethylene oxide (ETO).
NovoMix 30 Penfill
The instructions inside the product has incorrect labelling: The customer medicine information has incomplete description of the active ingredient and its appearance. The pack insert incorrectly states: ‘Do not keep the NovoMix® 30 Penfill® that you are using, or that you are carrying as a spare, with you. The storage conditions are correctly stated on the product carton. The correct statement reads: ‘You can carry the NovoMix® 30 Penfill® that you are using, or that you are carrying as a spare, with you. You can keep it at room temperature (not above 30°C) or in a refrigerator (2°C - 8°C) for up to 4 weeks.’
NovoRapid FlexPen
The storage instructions inside the product has incorrect labelling. The pack insert incorrectly states: ‘Do not keep the NovoRapid® FlexPen® that you are using, or that you are carrying as a spare, with you. The storage conditions are correctly stated on the product carton. The correct statement reads: ‘You can carry the NovoRapid® FlexPen® that you are using, or that you are carrying as a spare, with you. You can keep it at room temperature (not above 30°C) or in a refrigerator (2°C - 8°C) for up to 4 weeks.’
Fiasp FlexTouch
The storage instructions inside the product has incorrect labelling. The pack insert incorrectly states: ‘Do not keep the Fiasp® FlexTouch® that you are using, or that you are carrying as a spare, with you. The storage conditions are correctly stated on the product carton. The correct statement reads: ‘You can carry the Fiasp® FlexTouch® that you are using, or that you are carrying as a spare, with you. You can keep it at room temperature (not above 30°C) or in a refrigerator (2°C - 8°C) for up to 4 weeks.’
Wireless Recharger Model WR9220 and WR9200 for Rechargeable Implanted Neurostimulator
The Medtronic WR9220 and WR9200 Rechargers may become unresponsive when: the product is fully depleted; and placed on the dock; and quickly removed within 20 seconds, interrupting the initialisation routine. When the Wireless Recharger becomes unresponsive, the Wireless Recharger: will not respond to a button press cannot pair with the recharger app the recharger battery indicator will flash continuously when placed on the battery dock.
Invacare Perfecto2 V Oxygen Concentrator
The sound abatement washer may break down resulting in metal on metal wear inside the Pressure Equalisation (PE) valve. This may lead to high temperatures and overheating, separation of the shroud from the device, and loud noise, and can result in a fire that will shut down the device.
Lidocaine Hydrochloride Topical Solution USP, 4%, 50mL
The Lidocaine Hydrochloride topical solution can become stronger than intended.
Althea THC18
The level of tetrahydrocannabinol (THC) in this batch is too low and outside of the labelled concentration.
MiniMed Remote Controller MMT-503 used with MiniMed 508 Insulin Pump or Paradigm Pumps
An unauthorised individual in close proximity to an insulin pump user could potentially copy the wireless RF signals from the user’s remote controller and play those back later to deliver an additional bolus of insulin to the pump user or to suspend insulin delivery.
mySugr Bolus Calculator App (on Android)
When multiple devices are used on one account and certain changes in setting are made, a software bug on an Android device may cause the app to recommend an incorrect insulin reading.
DS Maref LX9 Sequential Pneumatic Compression Device
A fault in the programming of the LX9 pumps, may cause users to experience higher pressure in the garments than set on the device.
The Neuro Zti EVO and CLA Cochlear Implants
The implant may stop working due to a complete loss of communication between the implant and the sound processor.
MiniMed 640G and 670G Insulin Pumps
If the pump retainer ring breaks, the reservoir may become loose and may not lock into the pump.
MIC Gastrostomy Feeding Tubes - expanded recall
The Instructions For Use leaflet was not supplied with the product. The Instructions For Use provide important safety information for the user.
Trilogy Evo O2 and Trilogy Evo Portable Ventilators
Two software issues have been identified that relate to a pressure increase in the ventilators. 1. Infant/Pediatric External Flow Sensor (EFS) Calibration Pressure increase. An increase in the expiratory pressure (EPAP/PEEP) can occur when the paediatric/infant External Flow Sensor is used with an Active Flow or Dual Limb circuit and a manual circuit calibration is performed. 2. Pressure Drift (Continuous Usage). When a Trilogy Evo or Trilogy Evo O2 model is used continuously without any interruption to therapy, the baseline pressure may increase or decrease.
Philips M5072A Infant/Child SMART Pads Cartridge - External Defibrillator Electrode
Certain M5072A Infant/Child SMART Pads Cartridges (LOT Number Y111220-01) contain an incorrect image underneath the PULL handle on the protective cover that shows the pad placement for an adult’s chest (Figure 2). The image on the protective cover should show a drawing of pad placement for a child’s chest and back (Figure 1). The image is correct on the outer pouch that contains the infant/child pads cartridge (Figure 3).
Ruzurgi Amifampridine 10 mg Tablet Bottle
The affected product batch 18039 exceeds the specification for total yeast and mould counts (TYMC).
Cerabone Granules and Mucoderm (multiple sizes)
The product's patient information leaflet and patient implant card have been left out when the products were supplied. The implantation card and patient information sheet provide traceability of the products and important safety information for the patient.
DuoDERM Extra Thin and DuoDERM CGF adhesive wound dressings
The packaging of the adhesive wound dressings is not sealed together completely, leaving partial or fully open seals. The product may become non-sterile if the seal is open.
Sym Balance 90 Tablets
Bottles in affected batch number 754020 are mislabelled. These bottles may contain Para Tone multi-vitamin tablets instead of Sym Balance multi-vitamin tablets.
Manjistadi Kashyam, Mahanarayana Oil, Kottamchukkadi Oil and Ayyapala Oil
The products were supplied in the Australian market without an active Australian Registry for Therapeutic Goods (ARTG) registration and which were also labelled to contain Azadirachta indica ‘Neem’, Melia azdarach, or Acorus calumus.
Configura Advance Chairs
The backrest may detach from the chair.