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TGA Action ID	RC-2026-RN-00742-1
Type of Product	Medical Device
Product Name/Description	NDI Passive Spheres 1,4,5,18 Spheres Product Code: 8800737, 8800739, 8800965, 8801002, 8801054 Lot Number(s): 2506061, 2511421, 2506071, 2510461, 2511441, 2503011, 2505451, 2506651, 2509651, 2509691, 2510621, 2511391, 2406081, 2406201, 2406231, 2503061, 2505481, 2510471, 2510671, 2510681, 2511221, 2511231, 2511241, 2406241, 2510691, 2511331
ARTG Number	182255
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Variability has been identified in the reflective material applied to a limited number of NDI Sterile Passive Sphere lots. The reflective coating is used to reflect infrared light from optical tracking cameras, allowing optical navigation systems to detect and track instruments during surgical procedures. The affected spheres may not be detected or tracked as intended by compatible navigation systems. This may result in reduced tracking robustness, non-recognition and reduced navigation accuracy. To date, LifeHealthcare has not recorded any adverse events associated with this problem.
Instructions for Customers/Users	Customers are to: - Immediately review their inventory and quarantine any product from the affected lots on hand; - Return a signed response form with details of all affected product on hand to be returned; and - Liaise with their local sales representative for replacement of affected product.
Action Commencement Date	28/09/2026
Responsible Entity	Life Healthcare Pty Ltd
Contact Information	regulatory@lifehealthcare.com.au - LifeHealthcare