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VERIFIED OFFICIAL-SOURCE INDEX

Recalls from Therapeutic Goods Administration in Australia – Page 3

Browse official recall notices for Australia, then compare the product and every listed identifier with the item you own.

Last updated: October 12, 2026 at 7:44 PM UTC · Official sources are checked throughout the day.

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162 current and recent recalls

Showing 81–120 of 162 notices · Page 3 of 5

Therapeutic Goods Administration · September 3, 2026

LEO+ Self-Expanding Nitinol Stent (Stent, vascular, intracranial) Recall: 3/09/2026 LEO+ Self-Expanding

Affected product
LEO+ Self-Expanding Nitinol Stent (Stent, vascular, intracranial)
Category
Medical device recalls
Hazard
3/09/2026 LEO+ Self-Expanding Nitinol Stent (Stent, vascular, intracranial) and Eclipse Balloon Catheter (Catheter, intravascular, occluding) Medical Device Recall Class II Hospital
Check affected LEO+ Self-Expanding Nitinol Stent (Stent, vascular, intracranial) identifiers →

Therapeutic Goods Administration · September 1, 2026

Artisan Link Pro and Artisan Link System. An in vitro diagnostic Recall: 1/09/2026 Artisan Link Pro and

Affected product
Artisan Link Pro and Artisan Link System. An in vitro diagnostic
Category
Medical device recalls
Hazard
1/09/2026 Artisan Link Pro and Artisan Link System. An in vitro diagnostic medical device (IVD). Medical Device Product Alert Class II Hospital
Check affected Artisan Link Pro and Artisan Link System. An in vitro diagnostic identifiers →

Therapeutic Goods Administration · September 1, 2026

Trinity Biotech Oxalate Reagent B and Oxalate Kit. An in vitro Recall: 1/09/2026 Trinity Biotech Oxalate

Affected product
Trinity Biotech Oxalate Reagent B and Oxalate Kit. An in vitro
Category
Medical device recalls
Hazard
1/09/2026 Trinity Biotech Oxalate Reagent B and Oxalate Kit. An in vitro diagnostic medical device (IVD) Medical Device Recall Class II Hospital
Check affected Trinity Biotech Oxalate Reagent B and Oxalate Kit. An in vitro identifiers →

Therapeutic Goods Administration · August 31, 2026

D-100 Hemoglobin A1c Analytical Calibrator/Cartridge Pack. An in Recall: 31/08/2026 D-100 Hemoglobin A1c

Affected product
D-100 Hemoglobin A1c Analytical Calibrator/Cartridge Pack. An in
Category
Medical device recalls
Hazard
31/08/2026 D-100 Hemoglobin A1c Analytical Calibrator/Cartridge Pack. An in vitro diagnostic medical device (IVD). Medical Device Product Alert Class II Hospital
Check affected D-100 Hemoglobin A1c Analytical Calibrator/Cartridge Pack. An in identifiers →

Therapeutic Goods Administration · August 31, 2026

CombiDiagnost R90, DigitalDiagnost 4, DigitalDiagnost C90, and Recall: Classification Class II Reason for

Affected product
CombiDiagnost R90, DigitalDiagnost 4, DigitalDiagnost C90, and
Category
Medical device recalls
Hazard
Classification Class II Reason for the Action Following implementation of PSC 10.1, Philips identified several problems affecting DigitalDiagnost and ProxiDiagnost/ CombiDiagnost systems: 1. The system may not enter a ready state for wall stand exposures when…
Check affected CombiDiagnost R90, DigitalDiagnost 4, DigitalDiagnost C90, and identifiers →

Therapeutic Goods Administration · August 31, 2026

Liquid Urine Control and Liquid Assayed Chemistry Control Premium Recall: 31/08/2026 Liquid Urine Control

Affected product
Liquid Urine Control and Liquid Assayed Chemistry Control Premium
Category
Medical device recalls
Hazard
31/08/2026 Liquid Urine Control and Liquid Assayed Chemistry Control Premium Plus. An in vitro diagnostic medical device (IVD) Medical Device Product Correction Class II Hospital
Check affected Liquid Urine Control and Liquid Assayed Chemistry Control Premium identifiers →

Therapeutic Goods Administration · August 31, 2026

Atellica CH Revised C Reactive Protein (RCRP). An in vitro Recall: 31/08/2026 Atellica CH Revised C Reactive

Affected product
Atellica CH Revised C Reactive Protein (RCRP). An in vitro
Category
Medical device recalls
Hazard
31/08/2026 Atellica CH Revised C Reactive Protein (RCRP). An in vitro diagnostic medical device (IVD) Medical Device Product Correction Class III Hospital
Check affected Atellica CH Revised C Reactive Protein (RCRP). An in vitro identifiers →

Therapeutic Goods Administration · August 28, 2026

Philips iCT, Ingenuity CT, and Brilliance CT 64 and IQon Spectral CT Recall: 28/08/2026 Philips iCT,

Affected product
Philips iCT, Ingenuity CT, and Brilliance CT 64 and IQon Spectral CT
Category
Medical device recalls
Hazard
28/08/2026 Philips iCT, Ingenuity CT, and Brilliance CT 64 and IQon Spectral CT systems Medical Device Product Correction Class II Hospital
Check affected Philips iCT, Ingenuity CT, and Brilliance CT 64 and IQon Spectral CT identifiers →

Therapeutic Goods Administration · August 28, 2026

Shiley Hi-Lo Evac Cuffed Tracheostomy Tubes supplied with a Hi-Lo Recall: 28/08/2026 Shiley Hi-Lo Evac

Affected product
Shiley Hi-Lo Evac Cuffed Tracheostomy Tubes supplied with a Hi-Lo
Category
Medical device recalls
Hazard
28/08/2026 Shiley Hi-Lo Evac Cuffed Tracheostomy Tubes supplied with a Hi-Lo cuff, standard 15 mm connector, obturator (where applicable), and tape tie. Medical Device Recall Class I Hospital
Check affected Shiley Hi-Lo Evac Cuffed Tracheostomy Tubes supplied with a Hi-Lo identifiers →

Therapeutic Goods Administration · August 27, 2026

VITROS Immunodiagnostic Products Anti-HAV Total Reagent Pack and Recall: 27/08/2026 VITROS Immunodiagnostic

Affected product
VITROS Immunodiagnostic Products Anti-HAV Total Reagent Pack and
Category
Medical device recalls
Hazard
27/08/2026 VITROS Immunodiagnostic Products Anti-HAV Total Reagent Pack and Total Calibrator. An in vitro diagnostic medical device (IVD) Medical Device Product Correction Class II Hospital
Check affected VITROS Immunodiagnostic Products Anti-HAV Total Reagent Pack and identifiers →

Therapeutic Goods Administration · August 21, 2026

All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000 Recall: 21/08/2026 All GEM PAKs for GEM

Affected product
All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000
Category
Medical device recalls
Hazard
21/08/2026 All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000 with iQM3. An in vitro diagnostic medical device (IVD). Medical Device Product Correction Class II Hospital
Check affected All GEM PAKs for GEM Premier 5000 with iQM2 and GEM Premier 7000 identifiers →

Therapeutic Goods Administration · August 21, 2026

BIOFIRE FILMARRAY TORCH System Base. An in vitro diagnostic medical Recall: 21/08/2026 BIOFIRE FILMARRAY

Affected product
BIOFIRE FILMARRAY TORCH System Base. An in vitro diagnostic medical
Category
Medical device recalls
Hazard
21/08/2026 BIOFIRE FILMARRAY TORCH System Base. An in vitro diagnostic medical device (IVD). Medical Device Product Correction Class II Hospital
Check affected BIOFIRE FILMARRAY TORCH System Base. An in vitro diagnostic medical identifiers →

Therapeutic Goods Administration · August 20, 2026

Clearview, Innovacon, InstAlert and Surestep hCG Tests. An in vitro Recall: 20/08/2026 Clearview, Innovacon,

Affected product
Clearview, Innovacon, InstAlert and Surestep hCG Tests. An in vitro
Category
Medical device recalls
Hazard
20/08/2026 Clearview, Innovacon, InstAlert and Surestep hCG Tests. An in vitro diagnostic medical device (IVD). Medical Device Product Correction Class II Hospital
Check affected Clearview, Innovacon, InstAlert and Surestep hCG Tests. An in vitro identifiers →

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