CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.

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:
    No UDI-DI (for export only); Serial numbers CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582.
  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 #AS200-103.

Product Codes/Lot Numbers:

No UDI-DI (for export only); Serial numbers CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0480-2025

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