🔍 RecallPedia

CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Class I - Dangerous
🏥 Medical Devices Recalled: November 21, 2019 Caire Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280
  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:
Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared for use in the US..
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.

Product Codes/Lot Numbers:

Serial Numbers: CBB5219310254, CBB5219310255, CBB5219310279, CBB5219310280

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0805-2020

Related Recalls