Z-0481-2025Class II

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2

Name: Z-0481-2025 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2
Creator: Caire, Inc.
Published: 2024-10-04
License: https://open.fda.gov/license/

Caire, Inc. / initiated 2024-10-04 / Completed / root cause: manufacturing process

FDA source

Caire, Inc. began a recall of CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2 on 2024-10-04. FDA classified it as Class II and gives the reason as "Potential failure of affected units to recharge the battery of the oxygen concentrators". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0481-2025
Classification: Class II
Status: Completed
Initiated: 2024-10-04
Posted: 2024-11-15
Recalling firm: Caire, Inc.
Product: CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Potential failure of affected units to recharge the battery of the oxygen concentrators.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued letters via email on and dated 10/4/2024 to their "sold-to" DME (durable medical equipment) distributors. The letter explained the reason for recall, identified the affected serial numbers and when they were shipped to the DME distributor, and requested the devices be returned to the recalling firm immediately. They are informed the devices will be replaced with new or repaired units. The DME distributor is to contact the CAIRE Customer Service via phone or email to arrange for return of the devices. A Response Form: Acknowledgement of Receipt was enclosed to indicate they have read and understand the recall instructions.
Quantity in commerce: 26 concentrators
Distribution: Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Product codes and lots: No UDI-DI (for export only); Serial numbers: CBB5224350777, CBB5224350774, CBB5224350743, CBB5224350723, CBB5224350710, CBB5224350653, CBB5224350648, CBB5224350636, CBB5224350606, CBB5224350583, CBB5224350580, CBB5224350575, CBB5224350573, CBB5224350567, CBB5224350512, CBB5224350510, CBB5224350509, CBB5224350508, CBB5224350498, CBB5224350492, CBB5224350490, CBB5224350475, CBB5224350474, CBB5224350468, CBB5224350460, and CBB5224350459.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0481-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0478-2025	Class II	Completed	Voluntary: Firm initiated	2024-11-27	2024-11-15
Z-0479-2025	Class II	Completed	Voluntary: Firm initiated	2024-11-27	2024-11-15
Z-0480-2025	Class II	Completed	Voluntary: Firm initiated	2024-11-27	2024-11-15
Z-0481-2025	Class II	Completed	Voluntary: Firm initiated	2024-11-27	2024-11-15

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)