AirFit F30 Full Face Mask and User Guide

Recall Insight

This FDA Devices action (record #Z-0541-2024) was formally reported on December 27, 2023, with the manufacturer initiating the action on November 20, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. ResMed Ltd. is listed as the recalling firm, operating out of Bella Vista, N/A. Federal records indicate 2,660,776 units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: 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 fe… Distribution data in the federal record shows the product reached: US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 3 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.