Device recall: AirFit N10 Nasal Masks and User Guide
Class I FDA enforcement event 93499. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
ResMed Ltd. started this device recall on 20 Nov 2023. The firm address in the FDA record is in Bella Vista. FDA put the recall in Class I. FDA event 93499 has 7 product records. The first FDA enforcement report date is 27 Dec 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
ResMed Ltd., Bella Vista, N/A, Australia.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
7 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0536-2024 | AirFit N10 Nasal Masks and User Guide | 199,796 | Class I | Ongoing | 27 Dec 2023 |
| Z-0537-2024 | AirFit F20 Full Face Mask and User Guide | 11,885,039 | Class I | Ongoing | 27 Dec 2023 |
| Z-0538-2024 | AirTouch F20 Full Face Mask and User Guide | 3,816,138 | Class I | Ongoing | 27 Dec 2023 |
| Z-0539-2024 | AirFit N20 Nasal Mask and User Guide | 7,724,968 | Class I | Ongoing | 27 Dec 2023 |
| Z-0540-2024 | AirTouch N20 Nasal Mask and User Guide | 424,309 | Class I | Ongoing | 27 Dec 2023 |
| Z-0541-2024 | AirFit F30 Full Face Mask and User Guide | 2,660,776 | Class I | Ongoing | 27 Dec 2023 |
| Z-0542-2024 | AirFit F30i Full Face Mask and User Guide | 2,037,323 | Class I | Ongoing | 27 Dec 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class I
- 10%
- Product records in this event
- 7Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Jun 2026 | Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory s | Device | Class I | 1 |
| 13 Sep 2023 | Astral 100 and Astral 150 ventilators | Device | Class I | 1 |
| 12 Dec 2019 | ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 | Device | Class I | 1 |
| 5 May 2015 | Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator. | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0536-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 93499. https://recallregister.com/fda/i/93499/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 93499?
- The event has 7 product records. The first record gives this quantity:
199,796
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 10% of the 917 device events that started in 2023 are in Class I.