CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.

Class I - Dangerous
🏥 Medical Devices Recalled: October 4, 2024 Caire Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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 #AS200-101.

Product Codes/Lot Numbers:

UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0479-2025

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