The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0542-2024·Announced 2023-12-27

AirFit F30i Full Face Mask Recalled Due to Magnetic Interference Risk

ResMed is recalling the AirFit F30i Full Face Mask due to potential magnetic interference with active medical implants and ferromagnetic objects. Safety warnings are being updated.

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: This is an FDA Class I recall, which establishes a minimum severity score of 4. The potential for magnetic interference with implanted medical devices poses a serious risk of harm, though no illnesses or injuries are currently reported.

Plain-English summary

ResMed Ltd. is recalling the AirFit F30i Full Face Mask and User Guide to address potential magnetic interference with patients' active medical implants and ferromagnetic implants or objects.

The masks contain magnets that can interfere with active medical implants that interact with magnets, as well as with metallic implants or objects containing ferromagnetic material. The company is updating contraindications and warnings regarding safe distance between the mask and medical devices or implants.

Approximately 2,037,323 units have been distributed nationwide in the United States, including Puerto Rico, Guam, and the Virgin Islands, as well as internationally to numerous countries. Patients using the AirFit F30i Full Face Mask, particularly those with implanted medical devices, should review the updated safety information and consult with their healthcare provider about safe use.

The recalled product

Product
AirFit F30i Full Face Mask and User Guide
Manufacturer
ResMed Ltd.
Category
Medical Device — Full Face Mask
Hazard
Affected units
2,037,323

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 638225/version 2020-02
  • and prior. UDI-DI/GTIN: 619498633326
  • 619498633067
  • 619498633012
  • 619498633340
  • 619498633302
  • 619498633333
  • 619498633050
  • 619498633319
  • 619498633005
  • 619498633135
  • 619498633128
  • 619498633364
  • 619498633388
  • 619498633371
  • 619498633401
  • 619498633395
  • 619498633104
  • 619498633142
  • 619498633111

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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