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

Class I - Dangerous

🏥 Medical Devices Recalled: October 4, 2024 Caire Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Caire, Inc.
Reason for Recall:: Potential failure of affected units to recharge the battery of the oxygen concentrators.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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.