FDAClass IINovember 27, 2024

CAIRE FreeStyle Comfort portable oxygen concentrator recall

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

Why was CAIRE FreeStyle Comfort portable oxygen concentrator recalled?

Potential failure of affected units to recharge the battery of the oxygen concentrators.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
Recalling firm
Caire, Inc.
Quantity
26 concentrators
Distribution
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Recall date
November 27, 2024
Classification
Class II
Status
Completed
Agency
FDA (device)
Open FDA enforcement record Latest recalls