AirFit N20 Nasal Mask and User Guide
Class I - DangerousWhat Should You Do?
- Check if you have this product: All mask lots used with User Guide 638218/version 2020-02, 638243/version 2020-06, and prior. UDI-DI/GTIN: 619498635016, 619498635054, 619498635061, 619498635351, 619498635047, 619498635030, 619498635078, 619498635382, 619498635023, 619498635344, 619498635009, 619498635399, 619498635115, 619498635122, 619498635375, 619498635214, 619498635221, 619498635252, 619498635245, 619498635313, 619498635337, 619498635207, 619498635320, 619498635238, 619498635092, 619498635108, 619498635306, 619498635290, 619498635184, 619498635146, 619498635160, 619498635139, 619498635177, 619498635153
- 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 N20 Nasal Mask and User Guide
Product Codes/Lot Numbers:
All mask lots used with User Guide 638218/version 2020-02, 638243/version 2020-06, and prior. UDI-DI/GTIN: 619498635016, 619498635054, 619498635061, 619498635351, 619498635047, 619498635030, 619498635078, 619498635382, 619498635023, 619498635344, 619498635009, 619498635399, 619498635115, 619498635122, 619498635375, 619498635214, 619498635221, 619498635252, 619498635245, 619498635313, 619498635337, 619498635207, 619498635320, 619498635238, 619498635092, 619498635108, 619498635306, 619498635290, 619498635184, 619498635146, 619498635160, 619498635139, 619498635177, 619498635153
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0539-2024
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