Therapeutic Goods Administration · August 18, 2026
- Affected product
- Sundaze Polaris 29% THC Flower 10g Jar
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action Sundaze Polaris 29% THC Dried Flower 10g Jar primary container labels have an incorrect machine-readable barcode printed on the packaging. The printed barcode duplicates that of Sundaze Apollo (20% THC Dried…
Check affected Sundaze Polaris 29% THC Flower 10g Jar identifiers →Therapeutic Goods Administration · August 18, 2026
- Affected product
- PALACOS R+G pro 40, 60, 80 CE EUR and PALACOS MV+G pro 40, 60, 80 CE
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action There have been isolated cases of monomer liquid leaking from the pro system. Assessments carried out to date have shown that the system can continue to be used as intended. However, if the product does leak, the…
Check affected PALACOS R+G pro 40, 60, 80 CE EUR and PALACOS MV+G pro 40, 60, 80 CE identifiers →Therapeutic Goods Administration · August 18, 2026
- Affected product
- MEDICIANZ MUPIROCIN OINTMENT Mupirocin 2%w/w Tube
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action During ongoing stability testing, an out of specification (OOS) result was obtained for the stability batch (Batch No. S062409.1) at the 24-month testing point for both the assay (content) of Mupirocin and related…
Check affected MEDICIANZ MUPIROCIN OINTMENT Mupirocin 2%w/w Tube identifiers →Therapeutic Goods Administration · August 18, 2026
- Affected product
- iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. An in vitro
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Beckman Coulter has received customer complaints about lamina fluid leaks in iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. Investigation determined that the leaks are caused by a check valve in the rinse…
Check affected iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers. An in vitro identifiers →Therapeutic Goods Administration · August 17, 2026
- Affected product
- Various Blood Transfusion Sets, Basic Intravenous Administration
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action ICU Medical received reports of discolouration observed in the drip chambers of certain IV tubing sets. Instructions for Customers/Users ICU Medical's investigation into the problem confirmed that the observed…
Check affected Various Blood Transfusion Sets, Basic Intravenous Administration identifiers →Therapeutic Goods Administration · August 14, 2026
- Affected product
- Incisive CT and CT 5300 with software version 5.1.2.X
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Philips has identified multiple software problems in software version 5.1.2.X affecting Philips Incisive CT and CT 5300 systems. These problems may affect system performance and result in image reconstruction…
Check affected Incisive CT and CT 5300 with software version 5.1.2.X identifiers →Therapeutic Goods Administration · August 14, 2026
- Affected product
- Hemospray Endoscopic Hemostat
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Cook Medical is updating the Hemospray Instructions for Use (IFU) to include new guidance to address two Hemospray potential problems: 1. Endoscope adhesion and 2. Inability to spray powder. Cook Medical is not…
Check affected Hemospray Endoscopic Hemostat identifiers →Therapeutic Goods Administration · August 14, 2026
- Affected product
- VITROS Chemistry Products VALP Reagent. An in vitro diagnostic
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action QuidelOrtho confirmed a problem involving VITROS Chemistry Products VALP Reagent. Lots from Generations (GENs) 35, 36, and 37 may generate positively biased results. QuidelOrtho’s investigation into the problem…
Check affected VITROS Chemistry Products VALP Reagent. An in vitro diagnostic identifiers →Therapeutic Goods Administration · August 13, 2026
- Affected product
- Portrait Core Services Software version V1.0.5, V1.1 and V1.2
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action GE HealthCare has become aware that during a service event to update Portrait Core Services software at a facility, patients who are monitored on Portrait Mobile devices can be discharged from the Portrait…
Check affected Portrait Core Services Software version V1.0.5, V1.1 and V1.2 identifiers →Therapeutic Goods Administration · August 13, 2026
- Affected product
- Cardioroot Woven Grafts
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Internal testing of samples from CARDIOROOT vascular grafts produced Integral Water Permeability (IWP) results outside the limit specified in the product’s Instructions for Use (IFU) (i.e. Instructions for…
Check affected Cardioroot Woven Grafts identifiers →Therapeutic Goods Administration · August 13, 2026
- Affected product
- Eribulin 1 mg/2 mL Solution for Injection
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Dr. Reddys has identified an out of specification result during stability testing. The assay result reported (93.3 %) is below the registered specification of 95 -100%. Patients receiving this product may be…
Check affected Eribulin 1 mg/2 mL Solution for Injection identifiers →Therapeutic Goods Administration · August 12, 2026
- Affected product
- Adaptable Beach Chair Positioning Kit
- Category
- Medical device recalls
- Hazard
- Classification Class I Reason for the Action Quantum OPS Adaptable Beach Chair Positioning Kits may be affected by a fracture of a welded joint below the patient headrest. The affected welded joint provides structural support for the patient headrest. The…
Check affected Adaptable Beach Chair Positioning Kit identifiers →Therapeutic Goods Administration · August 11, 2026
- Affected product
- Orthopaedic implant components manufactured from ultra-high
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Certain orthopaedic implants were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five (5) years. Industry guidance for storage duration of UHMWPE raw material…
Check affected Orthopaedic implant components manufactured from ultra-high identifiers →Therapeutic Goods Administration · August 11, 2026
- Affected product
- POWERSEAL 5 MM (in diameter) 23 CM (long) Curved Jaw Sealer &
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Lot FR490902 may contain a labelling discrepancy. Specifically, the affected units were packaged in an outer shelf box labelled for a 37cm device versus an outer shelf box labelled for a 23cm device. However, other…
Check affected POWERSEAL 5 MM (in diameter) 23 CM (long) Curved Jaw Sealer & identifiers →Therapeutic Goods Administration · August 10, 2026
- Affected product
- Azurion R2.x.10, R3.0, R3.1 and R4.0 systems
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Philips has identified 2 potential problems that may lead to delay of therapy, procedural complications and/or inappropriate treatment. • Problem 1: Image quality degradation A problem associated with the Flat…
Check affected Azurion R2.x.10, R3.0, R3.1 and R4.0 systems identifiers →Therapeutic Goods Administration · August 7, 2026
- Affected product
- StrykeFlow PS and AHTO Tube Sets
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action There has been an increase in reported complaints describing leaking from the device during use. During use, the device may experience fluid leakage from the handpiece, which may result in fluid accumulating on the…
Check affected StrykeFlow PS and AHTO Tube Sets identifiers →Therapeutic Goods Administration · August 7, 2026
- Affected product
- Pertuzumab 420mg in 0.9% Sodium Chloride in Polyolefin Bag
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Cairns Hospital reported on 11/08/2026 that a Pertuzumab infusion bag (BB26084718) had expired prior to treatment. The single dose unit had expired during transit to the customer. The customer advised the single…
Check affected Pertuzumab 420mg in 0.9% Sodium Chloride in Polyolefin Bag identifiers →Therapeutic Goods Administration · August 6, 2026
- Affected product
- Bravo CF capsule delivery device, 5-pk
- Category
- Medical device recalls
- Hazard
- Classification Class I Reason for the Action Medtronic has identified an increase in complaints involving the Bravo CF capsule delivery device where the capsule fails to attach to the oesophagus or detach from the delivery device. Medtronic's preliminary root…
Check affected Bravo CF capsule delivery device, 5-pk identifiers →Therapeutic Goods Administration · August 6, 2026
- Affected product
- Meisinger Polishing 2 Step DPO02 204 040 / 2
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Surface cracks of varying severity may occur in the affected polishers. Depending on their extent, these cracks may be visible to different degrees and may impair the mechanical stability of the instrument.…
Check affected Meisinger Polishing 2 Step DPO02 204 040 / 2 identifiers →Therapeutic Goods Administration · August 5, 2026
- Affected product
- WaveWriter Alpha Spinal Cord Stimulation (SCS) System
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action Boston Scientific is notifying customers of an update to the Information for Prescribers and Information for Patients manuals used in Australia for applicable Boston Scientific WaveWriter Alpha Spinal Cord…
Check affected WaveWriter Alpha Spinal Cord Stimulation (SCS) System identifiers →Therapeutic Goods Administration · August 5, 2026
- Affected product
- Craft Botanics White Runtz T25 10g Jar (Dried Herb)
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action A labelling error has been identified for a specific batch of Craft Botanics White Runtz, following a customer complaint about a different organoleptic profile (appearance and aroma) compared to previous batches.…
Check affected Craft Botanics White Runtz T25 10g Jar (Dried Herb) identifiers →Therapeutic Goods Administration · August 4, 2026
- Affected product
- Fludeoxyglucose (18F) Injection (FDG)
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action It was identified there was a discrepancy of the recorded activity and volume supplied on the QC Release Forms than the actual activity and volume supplied in the customer vials. As such, the vials may not have met…
Check affected Fludeoxyglucose (18F) Injection (FDG) identifiers →Therapeutic Goods Administration · August 4, 2026
- Affected product
- Percutaneous Insertion Kits (PIK)
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action It was identified that there have been failures in sterile barrier integrity verification testing. As these failures were not previously addressed in accordance with packaging verification requirements, the…
Check affected Percutaneous Insertion Kits (PIK) identifiers →Therapeutic Goods Administration · August 3, 2026
- Affected product
- LATITUDE Clarity Server Software
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action There is a potential for a delay in AF Burden Alert notification affecting the LATITUDE Clarity server software which supports the LUX-Dx family of ICMs. This delayed AF Burden Alert notification behaviour by…
Check affected LATITUDE Clarity Server Software identifiers →Therapeutic Goods Administration · August 3, 2026
- Affected product
- OPTIRAY 350 Ioversol 74% w/v 74.1g/100mL Injection Vial
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action The vial label of some batches of Optiray 350 100 mL vials is incorrect. It lists the ingredients' quantities for Optiray 350 75 mL vial instead. The ingredients' quantities listed on the product carton are…
Check affected OPTIRAY 350 Ioversol 74% w/v 74.1g/100mL Injection Vial identifiers →Therapeutic Goods Administration · August 3, 2026
- Affected product
- XScribe Cardiac Stress Testing System
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action Some Q-Stress and XScribe systems experience a problem with the Windows 11 image installed on affected computers. Users may observe a Windows system warning message upon startup that prevents the installation of…
Check affected XScribe Cardiac Stress Testing System identifiers →Therapeutic Goods Administration · August 3, 2026
- Affected product
- GS1-HT Extraction Script for use within EasyScreen Sample Processing
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action The impacted extraction scripts contain a missing section of error-handling code for sample positions 81–95. If a low-volume or missing-sample condition occurs in positions 81 - 95, the script may apply recovery…
Check affected GS1-HT Extraction Script for use within EasyScreen Sample Processing identifiers →Therapeutic Goods Administration · July 31, 2026
- Affected product
- GYNECARE TVT EXACT Continence System
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action The manufacturer, Ethicon SARL, has identified a problem whereby white particulates were observed within the sterile barrier of certain LOTs. The manufacturer has determined that the white particulates originated…
Check affected GYNECARE TVT EXACT Continence System identifiers →Therapeutic Goods Administration · July 31, 2026
- Affected product
- Mindray Monitors
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Mindray has identified that certain monitor manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions. To improve clarity and ensure…
Check affected Mindray Monitors identifiers →Therapeutic Goods Administration · July 30, 2026
- Affected product
- Beckman Coulter Chemistry Analyzer AU480. An in vitro diagnostic
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Beckman Coulter has determined that CHEMISTRY ANALYZER AU480 with Windows 10 IoT Enterprise 2021 LTSC PCs listed above may output the message “System Stopped By Fatal Error: DBConnectionError AlarmDB when launching…
Check affected Beckman Coulter Chemistry Analyzer AU480. An in vitro diagnostic identifiers →Therapeutic Goods Administration · July 29, 2026
- Affected product
- Rua Puawai THC24
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action Rua Puawai THC24 was intended for supply in the New Zealand market; however, affected stock was supplied in error to two Australian pharmacies in place of Rua Puawai T24. No other batches of Rua Puawai THC24 have…
Check affected Rua Puawai THC24 identifiers →Therapeutic Goods Administration · July 29, 2026
- Affected product
- High Filtration Surgical Face Masks with Ties Level 3
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action The Therapeutic Goods Administration (TGA) conducted a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). Med-Con Pty Ltd was found to have supplied four batches of…
Check affected High Filtration Surgical Face Masks with Ties Level 3 identifiers →Therapeutic Goods Administration · July 29, 2026
- Affected product
- SACRO Sacrocolpopexy Tips
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action Certain LOTs were assembled with an internal hub in the incorrect orientation. The inverted assembly prevents the tip from being attached to the compatible RUMI system or Advincula Arch handle. If the SACRO…
Check affected SACRO Sacrocolpopexy Tips identifiers →Therapeutic Goods Administration · July 28, 2026
- Affected product
- GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Following a request from the US FDA to update the Instructions for Use (IFU) for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) during its review of the TAMBE 2026 IDE Annual Report (G150071/R061)…
Check affected GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) identifiers →Therapeutic Goods Administration · July 27, 2026
- Affected product
- Fludeoxyglucose (18F) Injection (FDG)
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Cyclotek was notified of a defective product (cracked vial), that was supplied to a customer site on 27 July 2026. The defect was identified upon receipt and was returned to the manufacturing facility. A new vial…
Check affected Fludeoxyglucose (18F) Injection (FDG) identifiers →Therapeutic Goods Administration · July 26, 2026
- Affected product
- Bendamustine HCL 159mg in 0.9% Sodium Chloride in Polyolefin Bag
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action Upon receipt of compounded product, Bendamustine, the customer has identified a leaking product within the protective inner clear bag. The spill was contained within the bag and deemed not safe for patient use. The…
Check affected Bendamustine HCL 159mg in 0.9% Sodium Chloride in Polyolefin Bag identifiers →Therapeutic Goods Administration · July 3, 2026
- Affected product
- Panocell 16. An in vitro diagnostic medical device (IVD)
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action Antibody identification testing performed with Donor B11752 (cell 11 of lot 17453/17453Z) may show positive reactions in the presence of Anti-P1, while the negative antigen from the master list would suggest a…
Check affected Panocell 16. An in vitro diagnostic medical device (IVD) identifiers →Therapeutic Goods Administration · June 5, 2026
- Affected product
- Stella 2.0 Implant Orientation Diagram (IOD) Incorrect Axis
- Category
- Medical device recalls
- Hazard
- Classification Class II Reason for the Action STAAR Surgical has become aware that a limited number of IODs generated have the risk of an IOD with an incorrect axis value that could be clinically significant. Specifically, per the review of data in Stella 2.0,…
Check affected Stella 2.0 Implant Orientation Diagram (IOD) Incorrect Axis identifiers →Therapeutic Goods Administration · April 29, 2026
- Affected product
- Fertilisation Medium FEM-50
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action The endotoxin testing method has changed due to the end of life of the testing kits used by Genea Biomedx for quantifying endotoxin levels. The Instructions for Use (IFU) was not updated to remove the mention of…
Check affected Fertilisation Medium FEM-50 identifiers →Therapeutic Goods Administration · November 4, 2025
- Affected product
- Getinge Assured Batch Monitoring PCD
- Category
- Medical device recalls
- Hazard
- Classification Class III Reason for the Action Getinge has identified a problem with certain Getinge Assured Batch Monitoring PCD units, where the required O-ring was not installed during manufacture following a customer complaint. The root cause was…
Check affected Getinge Assured Batch Monitoring PCD identifiers →
