The Recall Desk
SevereFDA (Devices)·Z-0536-2024·Announced 2023-12-27

ResMed AirFit N10 Nasal Masks Recalled for Magnetic Interference with Medical Implants

ResMed is recalling AirFit N10 Nasal Masks because magnets in the masks may interfere with active medical implants. Patients with such implants should consult their healthcare provider before using these masks.

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 is a FDA Class I medical device recall for a product containing magnets that may cause interference with implanted medical devices. Although no illnesses or injuries have been reported, the FDA Class I classification mandates a minimum Severe rating due to the potential for serious harm.

Plain-English summary

ResMed Ltd. is recalling AirFit N10 Nasal Masks and User Guide (628153/version 2020-07 and prior versions) because the masks contain magnets that may cause magnetic interference with active medical implants that interact with magnets and with metallic implants or objects containing ferromagnetic material.

The recall affects 199,796 units distributed nationwide in the United States (including Puerto Rico, Guam, and the Virgin Islands) and internationally. All mask lots used with the affected User Guide versions are included.

Patients who use these masks and have implanted medical devices should consult their healthcare provider before use to determine whether their implants may be affected by the magnetic field. ResMed is updating the product warnings and contraindications to provide information about safe distance and precautions related to the magnetic field generated by the masks.

The recalled product

Product
AirFit N10 Nasal Masks and User Guide
Manufacturer
ResMed Ltd.
Category
Medical Device — Respiratory Mask
Hazard
Affected units
199,796

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 628153/version 2020-07
  • and prior. UDI-DI/GTIN: 619498632008
  • 619498632893
  • 619498632060
  • 619498632077
  • 619498632299
  • 619498632015
  • 619498632084
  • 619498632022
  • 619498632237
  • 619498632190
  • 619498632213
  • 619498632220
  • 619498632183
  • 619498632206
  • 619498632268
  • 619498632244
  • 619498632114
  • 619498632251
  • 619498632091

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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