Facility

NORTHERN DIGITAL, INC.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

2inspections · worst OAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002743211
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198; Export Device to the United States But Perform No Other Operation on Device
Location	103 RANDALL DRIVE WATERLOO Ontario, CA N2V 1C5
Registration status	Active · expires 2026
Parent company	NORTHERN DIGITAL, INC. (owner-operator 9059739)
Brand names	NDI Passive Sphere

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Neurological Stereotaxic Instrument
Product code HAW (opens in a new tab) · Class II · Neurology · 21 CFR 882.4560

Recalls & enforcement

Class IITerminated2015-06-10
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Class IITerminated2015-05-20
Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.

FDA inspections (2)

OAI2025-08-28
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2024-08-14
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by NORTHERN DIGITAL, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NORTHERN DIGITAL, INC. (FEI 3002743211) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002743211-northern-digital-inc/

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