AirFit N10 Nasal Mask – Magnetic Interference (2023)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AirFit N10 Nasal Masks and User Guide
Lot Codes / Batch Numbers
All mask lots used with User Guide 628153/version 2020-07, and prior. UDI-DI/GTIN: 619498632008, 619498632893, 619498632060, 619498632077, 619498632299, 619498632015, 619498632084, 619498632022, 619498632237, 619498632190, 619498632213, 619498632220, 619498632183, 619498632206, 619498632268, 619498632244, 619498632114, 619498632251, 619498632091, 619498632107, 619498632152, 619498632121, 619498632138, 619498632275, 619498632169, 619498632145, 619498632176
Products Sold
All mask lots used with User Guide 628153/version 2020-07, and prior. UDI-DI/GTIN: 619498632008, 619498632893, 619498632060, 619498632077, 619498632299, 619498632015, 619498632084, 619498632022, 619498632237, 619498632190, 619498632213, 619498632220, 619498632183, 619498632206, 619498632268, 619498632244, 619498632114, 619498632251, 619498632091, 619498632107, 619498632152, 619498632121, 619498632138, 619498632275, 619498632169, 619498632145, 619498632176
A medical device manufacturer is recalling AirFit N10 Nasal Masks and User Guide due to Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
On 11/20/23, "Urgent Field Safety Notices" and FAQs were placed on the firms website at www.resmed.com/magnetupdate, and these notices were emailed to healthcare providers, and distributors who were asked to do the following: 1) Provide a copy of this notice and the physician letter to prescribing physicians, and/or any other relevant healthcare professionals, notifying them of the updated labeling (contraindications and warning). 2) Provide a copy of the patient letter to all patients currently using an affected mask with magnets, notifying them of the updated labeling (contraindications and warning). Note, patients are instructed in the patient letter to contact their mask provider for a replacement mask if they are now contraindicated. 3) Provide a replacement mask for contraindicated patients to an alternative mask without magnets in a timely manner. Where an alternative mask is not available, inform patients to consult with their physician. 4) Instruct patients to consult their physician and/or manufacturer of their implant / other medical device if they require additional information on the potential adverse effects of magnetic fields for their particular device (as described in warnings). 5) For alternative mask options, please contact your ResMed or Customer Service representative. 6) Complete and return the customer acknowledgement form via email to magnetresponse@resmed.com For any questions, please contact your local ResMed contact or visit www.resmed.com/contact.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026