Facility

Gynex Corporation

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

Key facts

1recalls · worst Class III

2inspections · 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)	3001238683
Establishment type	Repack or Relabel Medical Device
Location	6631 Browning Dr North Richland Hills, TX, US 76180
Registration status	Active · expires 2026
Parent company	GYNEX CORP. (owner-operator 9031621)
Brand names	TouchGuard Infrared Thermometer

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Continuous Measurement Thermometer
Product code FLL (opens in a new tab) · Class II · General Hospital · 21 CFR 880.2910

Recalls & enforcement

Class IIITerminated2012-09-06
The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable.

FDA inspections (2)

VAI2020-01-06
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-05-27
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 GYNEX CORP.

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. “Gynex Corporation (FEI 3001238683) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001238683-gynex-corporation/

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