The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0538-2024·Announced 2023-12-27

AirTouch F20 Full Face Mask Recalled for Magnetic Interference with Medical Implants

ResMed recalls 3.8 million AirTouch F20 full face masks with magnets that may interfere with active medical implants. Updated safety warnings regarding safe distances from medical devices are being issued.

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 recall classification indicates serious potential consequences. The masks contain magnets that pose potential magnetic interference with active medical implants and ferromagnetic objects, which could compromise the function of critical medical devices.

Plain-English summary

ResMed Ltd. is recalling 3,816,138 AirTouch F20 full face masks used with User Guide 638220 (version 2020-02 and prior) due to magnets in the mask that have potential to cause magnetic interference with certain medical implants.

The masks are non-invasive airflow interfaces for patients. They contain magnets that may interfere with active medical implants that interact with magnets and with metallic implants or objects containing ferromagnetic material. This potential magnetic interference poses a risk to patients who use the masks or to anyone in close physical contact with a patient wearing the mask.

The FDA has classified this as a Class I recall. Affected users worldwide include the United States, U.S. territories (Puerto Rico, Guam, Virgin Islands), and numerous other countries. ResMed is updating contraindications and safety warnings regarding the safe distance between patients using these masks and medical devices or implants.

Patients using an AirTouch F20 mask who have active medical implants or ferromagnetic implants should consult their physician regarding safe use. Healthcare providers should advise patients of the potential risks and review updated safety information.

The recalled product

Product
AirTouch F20 Full Face Mask and User Guide
Manufacturer
ResMed Ltd.
Category
Medical Device — Respiratory Mask
Hazard
Affected units
3,816,138

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 638220/version 2020-02
  • and prior. UDI-DI/GTIN: 619498630028
  • 619498630189
  • 619498630172
  • 619498630141
  • 619498630059
  • 619498630097
  • 619498630080
  • 619498630011
  • 619498630004
  • 619498630042
  • 619498630066
  • 619498630134
  • 619498630073
  • 619498630035
  • 619498630158
  • 619498630165
  • 619498630523
  • 619498630530
  • 619498630516

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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