AirFit F20 Full Face Mask and User Guide
Class I - DangerousWhat Should You Do?
- Check if you have this product: All mask lots used with User Guide 638220/version 2020-02, 638238/version 2020-12, 638221/version 2020-01, and prior. UDI-DI/GTIN: 619498634019, 619498634484, 619498634460, 619498634002, 619498634453, 619498634033, 619498634569, 619498634477, 619498634026, 619498634040, 619498634491, 619498634507, 619498634521, 619498634538, 619498640065, 619498640072, 619498634064, 619498640096, 619498634316, 619498640058, 619498634118, 619498640119, 619498634071, 619498634248, 619498634217, 619498634224, 619498634330, 619498634200, 619498634347, 619498634323, 619498634309, 619498634255, 619498634231, 619498634279, 619498634286, 619498634262, 619498634057, 619498634293, 619498634095, 619498634088, 619498634361, 619498634378, 619498634354, 619498640218, 619498640201, 619498640225, 619498634132, 619498634187, 619498634163, 619498634101, 619498634156, 619498634125, 619498634170, 619498640089, 619498640140, 619498634149, 619498640102, 619498640126, 619498640133, 619498634194
- 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:
- ResMed Ltd.
- Reason for Recall:
- Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
AirFit F20 Full Face Mask and User Guide
Product Codes/Lot Numbers:
All mask lots used with User Guide 638220/version 2020-02, 638238/version 2020-12, 638221/version 2020-01, and prior. UDI-DI/GTIN: 619498634019, 619498634484, 619498634460, 619498634002, 619498634453, 619498634033, 619498634569, 619498634477, 619498634026, 619498634040, 619498634491, 619498634507, 619498634521, 619498634538, 619498640065, 619498640072, 619498634064, 619498640096, 619498634316, 619498640058, 619498634118, 619498640119, 619498634071, 619498634248, 619498634217, 619498634224, 619498634330, 619498634200, 619498634347, 619498634323, 619498634309, 619498634255, 619498634231, 619498634279, 619498634286, 619498634262, 619498634057, 619498634293, 619498634095, 619498634088, 619498634361, 619498634378, 619498634354, 619498640218, 619498640201, 619498640225, 619498634132, 619498634187, 619498634163, 619498634101, 619498634156, 619498634125, 619498634170, 619498640089, 619498640140, 619498634149, 619498640102, 619498640126, 619498640133, 619498634194
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0537-2024
Related Recalls
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact