OFFICIAL-SOURCE RECALL · CANADA
NDI Passive Spheres™ Recall: The sphere manufacturer has identified variation in
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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Is your product affected?
- Brand
- See official notice
- Product
- NDI Passive Spheres™
- Manufacturer
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The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
The sphere manufacturer has identified variation in the reflective material used on a limited number of sterile passive sphere lots. The reflective material is the outer coating of the sphere that reflects infrared light from the optical tracking cameras, enabling detection and tracking of instruments during navigation procedures. Medtronic has determined that this variability may affect the ability of the navigation system to detect and track the spheres. Potential impacts may include instrument verification failures, intermittent or lost tracking, red status tracking or navigation accuracy.
Hazard
The sphere manufacturer has identified variation in the reflective material used on a limited number of sterile passive sphere lots. The reflective material is the outer coating of the sphere that reflects infrared light from the optical tracking cameras, enabling detection and tracking of instruments during navigation procedures. Medtronic has determined that this variability may affect the ability of the navigation system to detect and track the spheres. Potential impacts may include instrument verification failures, intermittent or lost tracking, red status tracking or navigation accuracy.
Official recall notice
NDI Passive Spheres™
Agency: Health Canada
Official publication date: September 16, 2026
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