Public recall detail

NDI Passive Spheres™

2026-09-16

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Health products Health product recall
Quick summary

Quick summary: NDI Passive Spheres™. Reason: Health product recall. Category: Health products. Date: 2026-09-16.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: NDI Passive Spheres™. Reason: Health product recall. Category: Health products. Date: 2026-09-16.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandNorthern Digital Inc.
ProductNDI Passive Spheres™
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82633

Affected products

ProductNDI Passive Spheres™
LotMore than 10 numbers, contact manufacturer.
Model8801071
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionNDI Passive Spheres™
ProductNDI Passive Spheres™
LotMore than 10 numbers, contact manufacturer.
Model8801074
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionNDI Passive Spheres™
ProductNDI Passive Spheres™
LotMore than 10 numbers, contact manufacturer.
Model8801075
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionNDI Passive Spheres™

Issue

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesNorthern Digital Inc. 103 Randall Drive, Waterloo, Ontario, Canada, N2V 1C5
Recall date2026-09-01
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82633
Background{}
CompaniesNorthern Digital Inc. 103 Randall Drive, Waterloo, Ontario, Canada, N2V 1C5
AudiencesHealthcare
Source updated2026-09-16

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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