AirFit F20 Full Face Mask recalled for magnetic interference with medical implants
ResMed is recalling AirFit F20 Full Face Masks due to magnets that can interfere with active medical implants. Updated warnings will guide safe distances for patients and those in close contact.
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 an FDA Class I medical device recall. Although no illnesses or injuries have been reported and the hazard is potential rather than manifested, FDA Class I recalls require a minimum severity score of 4 per the classification rules.
Plain-English summary
ResMed Ltd. is recalling the AirFit F20 Full Face Mask and User Guide nationwide in the United States (including Puerto Rico, Guam, and the Virgin Islands) and in numerous international markets due to magnets embedded in the mask.
The masks contain magnets that can cause magnetic interference with active medical implants such as pacemakers and implantable defibrillators, as well as with metallic implants or ferromagnetic objects. This interference could potentially affect the function of these medical devices.
The recall affects all mask lots used with affected user guide versions. Patients using these masks and anyone in close physical contact with mask users should be aware of these contraindications and maintain safe distances from active medical implants.
ResMed is updating contraindications and warnings about safe distances from the masks for patients and close contacts. Consumers should review updated safety information and consult with their healthcare provider regarding safe use of their mask.
The recalled product
- Product
- AirFit F20 Full Face Mask and User Guide
- Manufacturer
- ResMed Ltd.
- Hazard
- magnetic-interference
- implant-hazard
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
- 638238/version 2020-12
- 638221/version 2020-01
- and prior. UDI-DI/GTIN: 619498634019
- 619498634484
- 619498634460
- 619498634002
- 619498634453
- 619498634033
- 619498634569
- 619498634477
- 619498634026
- 619498634040
- 619498634491
- 619498634507
- 619498634521
- 619498634538
- 619498640065
- 619498640072
- 619498634064
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27