CLASS I ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report

AirFit F30 Full Face Mask and User Guide recalled by ResMed

ResMed is recalling AirFit F30 Full Face Mask and User Guide, distributed nationwide in the US. The recall was initiated on 20 Nov 2023 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll mask lots used with User Guide 638234/version 2020-07, and prior. UDI-DI/GTIN: 619498641048, 619498641000, 619498641017, 619498641406, 619498641055, 619498641116, 619498641277, 619498641109, 619498641154, 619498641260, 619498641147

Quantity recalled2,660,776

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0541-2024
FDA event ID: 93499
Recalling firm: ResMed, Bella Vista, N/A
Classification: Class I
Status: Ongoing
Recall initiated: 20 Nov 2023
FDA classified: 21 Dec 2023
Reported: 27 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Masks, Gloves & PPE

Timeline

20 Nov 2023	Recall initiated by company
21 Dec 2023	Classified by FDA	+31 days
27 Dec 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing ferromagnetic material so contraindications and warnings about safe distance to medical devices/implants are being updated for patients using masks or anyone in close physical contact

Product as listed by the FDA

AirFit F30 Full Face Mask and User Guide

Where it was distributed

US nationwide distribution including Puerto Rico, Guam, and Virgin Islands. OUS (foreign) countries of: AE, AR, AT, AU, BB, BD, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CW, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FO, FR, GB, GF, GG, GL, GP, GR, GT, GY, HK, HN, HR, HU, ID, IE, IL, IM, IN, IR, IS, IT, JE, JO, JP, KE, KG, KR, KW, LB, LK, LT, LV, LY, MA, MC, MM, MQ, MT, MU, MV, MX, MY, NA, NC, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PM, PT, QA, RE, RO, RS, RU, SA, SD, SE, SG, SI, SK, SV, TH, TN, TR, TT, TW, UY, VE, VN, WF, YT, ZA

Nationwide Arkansas California Colorado Delaware Idaho Illinois Indiana Massachusetts Montana North Carolina Pennsylvania Puerto Rico South Dakota Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

All mask lots used with User Guide 638234/version 2020-07, and prior. UDI-DI/GTIN: 619498641048, 619498641000, 619498641017, 619498641406, 619498641055, 619498641116, 619498641277, 619498641109, 619498641154, 619498641260, 619498641147

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

6 other products · FDA event 93499

This product is part of a recall event; the main page for the event is AirTouch F20 Full Face Mask and User Guide recalled by ResMed.

Reported	Class	Recall	Company	Reason	Where
27 Dec 2023	CLASS I	AirTouch F20 Full Face Mask and User Guide recalled by ResMed	ResMed	Other	Nationwide
27 Dec 2023	CLASS I	AirTouch N20 Nasal Mask and User Guide recalled by ResMed	ResMed	Other	Nationwide
27 Dec 2023	CLASS I	AirFit N10 Nasal Masks and User Guide recalled by ResMed	ResMed	Other	Nationwide
27 Dec 2023	CLASS I	AirFit F20 Full Face Mask and User Guide recalled by ResMed	ResMed	Other	Nationwide
27 Dec 2023	CLASS I	AirFit F30i Full Face Mask and User Guide recalled by ResMed	ResMed	Other	Nationwide
27 Dec 2023	CLASS I	AirFit N20 Nasal Mask and User Guide recalled by ResMed	ResMed	Other	Nationwide

More recalls from ResMed

All 13

Reported	Class	Recall	Company	Reason	Where
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
27 Dec 2023Device	CLASS I	AirFit N20 Nasal Mask and User Guide recalled by ResMed	ResMed	Other	Nationwide
27 Dec 2023Device	CLASS I	AirFit F30i Full Face Mask and User Guide recalled by ResMed	ResMed	Other	Nationwide
27 Dec 2023Device	CLASS I	AirFit F20 Full Face Mask and User Guide recalled by ResMed	ResMed	Other	Nationwide
27 Dec 2023Device	CLASS I	AirFit N10 Nasal Masks and User Guide recalled by ResMed	ResMed	Other	Nationwide

Other Masks, Gloves & PPE recalls

All 447

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	P28 Phanton Intramedullary Nail System recalled by Paragon 28	Paragon 28	Sterility	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Adapter for Head Positioning recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
3 Jun 2026Device	CLASS II	Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled	O&M Halyard	Other	Nationwide