Z-0537-2024Class I

AirFit F20 Full Face Mask and User Guide

Name: Z-0537-2024 AirFit F20 Full Face Mask and User Guide
Creator: ResMed Ltd.
Published: 2023-11-20
License: https://open.fda.gov/license/

ResMed Corp / initiated 2023-11-20 / Open, Classified / root cause: design

FDA source

ResMed Ltd. began a recall of AirFit F20 Full Face Mask and User Guide on 2023-11-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0537-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-11-20
Posted: 2023-12-21
Recalling firm: ResMed Corp
Product: AirFit F20 Full Face Mask and User Guide
Product code: BZD Ventilator, Non-Continuous (Respirator)
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
Root cause tag: design
FDA root cause: Device Design
Action: On 11/20/23, "Urgent Field Safety Notices" and FAQs were placed on the firms website at www.resmed.com/magnetupdate, and these notices were emailed to healthcare providers, and distributors who were asked to do the following: 1) Provide a copy of this notice and the physician letter to prescribing physicians, and/or any other relevant healthcare professionals, notifying them of the updated labeling (contraindications and warning). 2) Provide a copy of the patient letter to all patients currently using an affected mask with magnets, notifying them of the updated labeling (contraindications and warning). Note, patients are instructed in the patient letter to contact their mask provider for a replacement mask if they are now contraindicated. 3) Provide a replacement mask for contraindicated patients to an alternative mask without magnets in a timely manner. Where an alternative mask is not available, inform patients to consult with their physician. 4) Instruct patients to consult their physician and/or manufacturer of their implant / other medical device if they require additional information on the potential adverse effects of magnetic fields for their particular device (as described in warnings). 5) For alternative mask options, please contact your ResMed or Customer Service representative. 6) Complete and return the customer acknowledgement form via email to [email protected] For any questions, please contact your local ResMed contact or visit www.resmed.com/contact.
Quantity in commerce: 11,885,039
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0537-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0536-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21
Z-0537-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21
Z-0538-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21
Z-0539-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21
Z-0540-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21
Z-0541-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21
Z-0542-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-27	2023-12-21

Product code BZD

K170924Class IIAirFit F20Resmed, Ltd. / cleared 2018-01-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)