Facility

BRYAN MEDICAL INC.

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

Key facts

2recalls · worst Class I

4inspections · 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)	3005803389
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	6100 Wooster Pike Cincinnati, OH, US 45227
Registration status	Active · expires 2026
Parent company	Bryan Medical Inc. (owner-operator 10029737)
Brand names	Tenax Laser Resistant Endotracheal Tube Convenience Kit

Activity by year

Recalls (2)
Inspections (4)

Devices registered here (1)

Orotracheal Intubation Guide Kit
Product code OGK (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.1400

Recalls & enforcement

Class IIOngoing2023-05-16
Devices were mislabeled.
Class ITerminated2013-04-17
The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

FDA inspections (4)

NAI2026-08-18
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2023-02-01
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2021-07-23
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2018-10-03
No Action Indicated · Compliance: 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 Bryan Medical 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. “BRYAN MEDICAL INC. (FEI 3005803389) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005803389-bryan-medical-inc/

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