---
title: "AirFit F20 Full Face Mask and User Guide — FDA record Z-0537-2024 | Is It on Recall"
description: "Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interac"
url: https://isitonrecall.com/recall/fda-device-z-0537-2024-airfit-f20-full-face-mask-and-user-guide/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# AirFit F20 Full Face Mask and User Guide — FDA record Z-0537-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: AirFit F20 Full Face Mask and User Guide
- **Reason**: 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
- **Classification**: Class I
- **Recalling firm**: ResMed Ltd.
- **Quantity**: 11,885,039
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0537-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0537-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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, 619498640096, 619498634316, 619498640058, 619498634118, 619498640119, 619498634071, 619498634248, 619498634217, 619498634224, 619498634330, 619498634200, 619498634347, 619498634323, 619498634309, 619498634255, 619498634231, 619498634279, 619498634286, 619498634262, 619498634057, 619498634293, 619498634095, 619498634088, 619498634361, 619498634378, 619498634354, 619498640218, 619498640201, 619498640225, 619498634132, 619498634187, 619498634163, 619498634101, 619498634156, 619498634125, 619498634170, 619498640089, 619498640140, 619498634149, 619498640102, 619498640126, 619498640133, 619498634194 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alaska](https://isitonrecall.com/state/alaska/)
- [Alabama](https://isitonrecall.com/state/alabama/)
- [Arkansas](https://isitonrecall.com/state/arkansas/)
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- [Utah](https://isitonrecall.com/state/utah/)
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- [Wyoming](https://isitonrecall.com/state/wyoming/)

## Dates in the source

- **Report date**: Dec 27, 2023
- **Recall initiation date**: Nov 20, 2023
- **Center classification date**: Dec 21, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0537-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [ResMed Ltd. records](https://isitonrecall.com/brand/resmed-ltd/)
