The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0539-2024·Announced 2023-12-27

AirFit N20 Nasal Mask: Magnetic Interference with Medical Implants

ResMed AirFit N20 Nasal Masks contain magnets that may interfere with active medical implants and ferromagnetic objects. The FDA classified this as Class I; ResMed is updating safety warnings with required distances.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I designation mandates a minimum score of 4. Although no illnesses or injuries have been reported, the potential for magnetic interference with active medical implants poses significant risk of harm to device function.

Plain-English summary

ResMed Ltd. is recalling the AirFit N20 Nasal Mask due to potential magnetic interference with medical implants. The masks contain magnets that may interfere with active medical implants and ferromagnetic metallic implants or objects.

The FDA classified this as a Class I recall. The magnetic field from the mask poses a potential risk of interference with implanted medical devices and ferromagnetic objects. ResMed is updating the product's safety warnings and contraindications to inform users about the hazard and safe distances from medical implants.

Patients using the AirFit N20 mask who have any type of implanted medical device or ferromagnetic implant should consult their healthcare provider and implant manufacturer before use. The updated user guides will provide information about safe distances to maintain between the mask and implanted devices.

ResMed is working with the FDA to ensure affected customers receive updated product information. Patients with questions should contact their healthcare provider or ResMed customer service.

The recalled product

Product
AirFit N20 Nasal Mask and User Guide
Manufacturer
ResMed Ltd.
Category
Medical Device — Respiratory Device
Hazard
Affected units
7,724,968

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 (20)

  • All mask lots used with User Guide 638218/version 2020-02
  • 638243/version 2020-06
  • and prior. UDI-DI/GTIN: 619498635016
  • 619498635054
  • 619498635061
  • 619498635351
  • 619498635047
  • 619498635030
  • 619498635078
  • 619498635382
  • 619498635023
  • 619498635344
  • 619498635009
  • 619498635399
  • 619498635115
  • 619498635122
  • 619498635375
  • 619498635214
  • 619498635221
  • 619498635252

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 →

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