ResMed recalls AirFit F20 Full Face Masks with potential magnetic interference affecting medical implants. Affected models include specific versions and lots. Consumers should check their mask details and contact ResMed for guidance.
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
ResMed is recalling AirFit F20 Full Face Masks that could interfere with medical implants due to magnets. This risk affects patients using the mask or those in close contact with the mask. The recall is for specific model versions and production lots.
The mask contains magnets that could interfere with active medical implants containing ferromagnetic material. This interference may cause unintended device activation or malfunction, potentially leading to health risks if the mask is used too close to medical implants.
Patients using the AirFit F20 Full Face Mask or individuals in close physical contact with the mask are at risk. Those with medical implants that interact with magnets are most vulnerable.
Check your mask's lot number and version code on the User Guide. Affected models include specific versions like 638220/version 2020-02 and 638238/version 2020-12. The UDI-DI/GTIN numbers listed in the recall are also unique identifiers for affected units.
Look for the lot number and version code on the User Guide to determine if your mask is affected.
Reach out to ResMed directly for guidance on whether your mask is affected and next steps.
The recall does not require immediate discontinuation; however, affected users should check their mask details and contact ResMed for specific guidance.
Affected versions include 638220/version 2020-02, 638238/version 2020-12, 638221/version 2020-01, and prior model lots with specific UDI-DI/GTIN numbers listed in the recall.
The recall does not mention a fix; affected users are advised to contact ResMed for guidance on whether their mask is affected.
We’ve drafted a message you can send ResMed to request your refund or repair — edit it as you like.
Subject: Recall Z-0537-2024 — ResMed ResMed Hello, I own a ResMed that is covered by recall Z-0537-2024 from ResMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.