Facility

SONEX HEALTH, Inc

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

Key facts

1recalls · worst Class II

—inspections in our data

—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)	3013479847
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198
Location	950 Blue Gentian Road Eagan, MN, US 55121
Registration status	Active · expires 2026
Parent company	Sonex Health, Inc (owner-operator 10053414)
Brand names	UltraGuideCTR

Activity by year

Recalls (1)

Devices registered here (1)

Arthroscope
Product code HRX (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.1100

Recalls & enforcement

Class IITerminated2022-06-29
Potential of dull blade

All facilities operated by Sonex Health, 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. “SONEX HEALTH, Inc (FEI 3013479847) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013479847-sonex-health-inc/

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