CLASS I ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report
AirFit N20 Nasal Mask and User Guide recalled by ResMed
ResMed is recalling AirFit N20 Nasal 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
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-0539-2024
- 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 N20 Nasal 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 ArkansasCaliforniaColoradoDelawareIdahoIllinoisIndianaMassachusettsMontanaNorth CarolinaPennsylvaniaPuerto RicoSouth DakotaTennessee
Questions about this recall
Is AirFit N20 Nasal Mask and User Guide recalled?
Yes. ResMed recalled AirFit N20 Nasal Mask and User Guide on 20 Nov 2023. The recall is Class I and its status is Ongoing. Recall number Z-0539-2024.
Why was it recalled?
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
Which lots are affected?
All mask lots used with User Guide 638218/version 2020-02, 638243/version 2020-06, and prior. UDI-DI/GTIN: 619498635016, 619498635054, 619498635061, 619498635351, 619498635047, 619498635030, 619498635078, 619498635382, 619498635023, 619498635344, 619498635009, 619498635399, 619498635115, 619498635122, 619498635375, 619498635214, 619498635221, 619498635252, 619498635245, 619498635313, 619498635337, 619498635207, 619498635320, 619498635238, 619498635092, 619498635108, 619498635306, 619498635290, 619498635184, 619498635146, 619498635160, 619498635139, 619498635177, 619498635153
Where was it sold?
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
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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