Z-0805-2020Class II

CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator -

Name: Z-0805-2020 CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator -
Creator: Caire, Inc.
Published: 2019-11-21
License: https://open.fda.gov/license/

Caire, Inc. / initiated 2019-11-21 / Terminated / root cause: packaging

FDA source

Caire, Inc. began a recall of CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of... on 2019-11-21. FDA classified it as Class II and gives the reason as "Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0805-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-21
Posted: 2020-01-13
Terminated: 2020-11-20
Recalling firm: Caire, Inc.
Product: CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm initiated the recall by telephone and email on 11/19/2019, then followed with a letter on 12/04/2019. The firm requested the removal of all units and will exchange them for the US approved version.
Quantity in commerce: 4 units
Distribution: US Nationwide distribution in the states of MI, CA, CT.
Product codes and lots: Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0805-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0805-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-13

Product code CAW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)