The U.S. Food and Drug Administration (FDA) took a grave stance on Thursday, categorizing a product recall initiated by ResMed (NYSE:RMD) for its respiratory care devices as a Class I recall – the most severe type possible.

Masking the Risks

The recalled products include the AirFit and AirTouch masks, which are utilized with bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP).

Danger Lurking Within

The issue at hand revolves around the mask’s magnetic components. The FDA has raised concerns that these components could potentially interfere with certain metallic objects, such as implanted medical devices like pacemakers, posing a risk of injury or even death.

Ripple Effects

Adverse effects could also extend to people in close proximity to individuals wearing the faulty masks. The products are compatible with BiPAP and CPAP machines from other manufacturers, and users of these devices are urged to ensure that their masks are not part of the recall.

Industry Reflection

ResMed’s competitors in the respiratory care market, including Philips (PHG) (OTCPK:RYLPF), Inspire Medical Systems (INSP), and Owens & Minor (OMI), are gaining attention in light of this development.

Speaking on the matter, ResMed (RMD) has not responded to Seeking Alpha’s requests for comments regarding the recall. However, the California-based MedTech firm made headlines earlier this week when it announced that its respiratory masks containing magnets would remain on the market, despite the FDA’s Class I recall classification. ResMed claimed that the classification indicated a labeling alteration, rather than a product recall.

Historical Parallel

ResMed’s product recall represents the most recent issue to plague the industry. Its European rival, Philips (PHG) (OTCPK:RYLPF), is currently tackling the aftermath of its 2021 decision to recall millions of sleep apnea and ventilator machines due to potential health risks.