Z-1117-2022Class II

CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3

Name: Z-1117-2022 CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Creator: Caire, Inc.
Published: 2022-03-25
License: https://open.fda.gov/license/

Caire, Inc. / initiated 2022-03-25 / Terminated

FDA source

Caire, Inc. began a recall of CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3 on 2022-03-25. FDA classified it as Class II and gives the reason as "The device was not cleared for U.S. distribution". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1117-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-25
Posted: 2022-05-19
Terminated: 2023-10-05
Recalling firm: Caire, Inc.
Product: CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Product code: CAW Generator, Oxygen, Portable
Reason for recall: The device was not cleared for U.S. distribution.
FDA root cause: No Marketing Application
Action: The recalling firm initially contacted the customer via voicemail and email on 3/25/2022. The email informed the consignee that the two affected units that were shipped to them could not be sold in the U.S. or its territories due to FDA approval. The email requested the consignee confirm their address so that call tags could be sent to them for return of the affected units. The consignee was informed the units will be replaced with the new AS200-1 units as soon as the recalled units are returned. The model and serial numbers were provided of the affected units. The voicemail message summarized the information that was in the email.
Quantity in commerce: 2 oxygen concentrators
Distribution: Distribution was made to Puerto Rico. There was no foreign/government/military distribution.
Product codes and lots: Serial numbers CBB5221200337 and CBB5221200287.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1117-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1117-2022	Class II	Terminated	Voluntary: Firm initiated	2022-05-25	2022-05-19

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)