Facility

CADWELL INDUSTRIES, INC.

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

Key facts

2recalls · worst Class II

1inspections · worst VAI

—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)	3020018
Establishment type	Manufacture Medical Device
Location	909 N Kellogg St KENNEWICK, WA, US 99336
Registration status	Active · expires 2026
Parent company	CADWELL INDUSTRIES, INC. (owner-operator 3020018)
Brand names	Cascade IOMAX; Cascade Surgical Studio SW

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (10)

Stimulator, Nerve
Product code ETN (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.1820
Device, Galvanic Skin Response Measurement
Product code GZO (opens in a new tab) · Class II · Neurology · 21 CFR 882.1540
Stimulator, Auditory, Evoked Response
Product code GWJ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1900
Non-Normalizing Quantitative Electroencephalograph Software
Product code OLT (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400
Stimulator, Photic, Evoked Response
Product code GWE (opens in a new tab) · Class II · Neurology · 21 CFR 882.1890
Oximeter
Product code DQA (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2700
Device, Nerve Conduction Velocity Measurement
Product code JXE (opens in a new tab) · Class II · Neurology · 21 CFR 882.1550
Electromyograph, Diagnostic
Product code IKN (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.1375
Full-Montage Standard Electroencephalograph
Product code GWQ (opens in a new tab) · Class II · Neurology · 21 CFR 882.1400
Stimulator, Electrical, Evoked Response
Product code GWF (opens in a new tab) · Class II · Neurology · 21 CFR 882.1870

Recalls & enforcement

Class IIOngoing2024-05-17
Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
Class IIOngoing2024-04-23
There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.

FDA inspections (1)

NAI2017-08-16
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 CADWELL INDUSTRIES, 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. “CADWELL INDUSTRIES, INC. (FEI 3020018) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3020018-cadwell-industries-inc/

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