Facility

CAIRE INC.

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

Key facts

5recalls · worst Class I

2inspections · 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)	3004972304
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	2200 Airport Industrial Dr Ste 500 Ball Ground, GA, US 30107
Registration status	Active · expires 2026
Parent company	CAIRE Inc. (owner-operator 9008476)
Brand names	Companion 21, 31, and 41

Activity by year

Recalls (5)
Inspections (2)

Devices registered here (1)

Unit, Liquid-Oxygen, Portable
Product code BYJ (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5655

Recalls & enforcement

Class IICompleted2024-10-04
Potential failure of affected units to recharge the battery of the oxygen concentrators.
Class ITerminated2022-10-10
An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
Class IITerminated2022-03-25
The device was not cleared for U.S. distribution.
Class IITerminated2019-11-21
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Class IITerminated2019-09-16
There is an electronics control issue that causes the unit to not power on with battery power only.

FDA inspections (2)

NAI2019-07-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2017-10-16
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. “CAIRE INC. (FEI 3004972304) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004972304-caire-inc/

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