The Recall Desk
SevereFDA (Devices)·Z-0541-2024·Announced 2023-12-27

AirFit F30 Full Face Mask recalled for magnetic interference with medical implants

ResMed is recalling the AirFit F30 Full Face Mask because the device contains magnets that can interfere with active medical implants and ferromagnetic objects. The original user guide did not adequately warn about safe distance requirements.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum severity score of Severe. The hazard—magnetic interference with active implantable medical devices—poses serious risk to patient safety by potentially affecting device function. Although no injuries have been reported, the potential for harm from implant interference is inherent to this device interaction.

Plain-English summary

The AirFit F30 Full Face Mask is a non-invasive respiratory interface device manufactured by ResMed Ltd. Approximately 2,660,776 units have been distributed in the United States, Puerto Rico, Guam, and the Virgin Islands, as well as internationally to multiple countries.

The masks contain magnets that can cause magnetic interference with active medical implants (such as pacemakers or neurostimulators) and ferromagnetic metallic implants or objects. The original user guide did not adequately warn about the safe distance required between the mask and these medical devices or implants. The concern affects patients using the mask as well as anyone in close physical contact with a mask-wearing patient.

ResMed is updating the user guide and product labeling to include appropriate contraindications and warnings about safe distance from medical devices and implants. Patients using the AirFit F30 mask, particularly those with active implantable medical devices or metallic implants, should consult the updated guidance. Healthcare providers and caregivers should also review the updated warnings. All users should speak with their healthcare provider regarding safe use of the device.

The recalled product

Product
AirFit F30 Full Face Mask and User Guide
Manufacturer
ResMed Ltd.
Category
Medical Device — Respiratory Support
Hazard
Affected units
2,660,776

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • All mask lots used with User Guide 638234/version 2020-07
  • and prior. UDI-DI/GTIN: 619498641048
  • 619498641000
  • 619498641017
  • 619498641406
  • 619498641055
  • 619498641116
  • 619498641277
  • 619498641109
  • 619498641154
  • 619498641260
  • 619498641147

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 7 recalled by ResMed Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Related recalls

Same manufacturer · ResMed Ltd.

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Same hazard · magnetic interference

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