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)	2129616
Establishment type	Manufacture Medical Device
Location	2205 Airport Industrial Dr Ball Ground, GA, US 30107
Registration status	Active · expires 2026
Parent company	CAIRE Inc. (owner-operator 9008476)
Brand names	Portable Liquid Oxygen, Spirit

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
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 2129616) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2129616-caire-inc/

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