Facility

STEREOTAXIS, INC.

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

Key facts

1recalls · worst Class II

1inspections · worst NAI

—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)	3003084417
Establishment type	Manufacture Medical Device
Location	710 N. Tucker Blvd., Suite 110 Saint Louis, MO, US 63101
Registration status	Active · expires 2026
Parent company	Stereotaxis (owner-operator 9048165)

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Wire, Guide, Catheter
Product code DQX (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1330
System, Catheter Control, Steerable
Product code DXX (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1290

Recalls & enforcement

Class IITerminated2020-09-21
There is a potential for fire in the inside computer cabinet.

FDA inspections (1)

NAI2016-01-19
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.

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. “STEREOTAXIS, INC. (FEI 3003084417) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003084417-stereotaxis-inc/

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