The Recall Desk
SevereFDA (Devices)·Z-0540-2024·Announced 2023-12-27

AirTouch N20 Nasal Mask recalled for magnetic interference with medical implants

ResMed is recalling 424,309 units of AirTouch N20 Nasal Masks because they contain magnets that may interfere with active medical implants and ferromagnetic materials. Updated safety warnings are being provided.

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: This FDA Class I recall receives a score of 4 per the rubric requirement that FDA Class I recalls never score below 4. No deaths or serious injuries have been reported in the source material. The hazard involves potential magnetic interference with active medical implants, which is a significant safety concern warranting the higher severity classification.

Plain-English summary

ResMed Ltd. is recalling the AirTouch N20 Nasal Mask and User Guide. The recall affects all mask lots used with User Guide version 2020-02 and prior. A total of 424,309 units were distributed in the United States (including Puerto Rico, Guam, and the Virgin Islands) and in over 60 countries worldwide.

The masks contain magnets that may cause magnetic interference with active medical implants and metallic objects or implants containing ferromagnetic material. Such interference could present a safety concern for patients using the mask and for anyone in close physical contact with the wearer.

ResMed is updating the product's contraindications and safety warnings to provide guidance on safe distances to maintain near medical devices and implants. Patients using this mask should review the updated safety information.

The recalled product

Product
AirTouch N20 Nasal Mask and User Guide
Manufacturer
ResMed Ltd.
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
424,309

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 (16)

  • All mask lots used with User Guide 638218/version 2020-02
  • and prior. UDI-DI/GTIN: 619498639069
  • 619498639045
  • 619498639052
  • 619498639021
  • 619498639038
  • 619498639007
  • 619498639076
  • 619498639014
  • 619498639540
  • 619498639205
  • 619498639229
  • 619498639113
  • 619498639090
  • 619498639120
  • 619498639212

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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