Device recall: Mojo Full Face with Headgear, All Sizes
Class I FDA enforcement event 94169. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Update to contraindications and warning language due to CPAP masks containing magnets.
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
SleepNet Corporation started this device recall on 1 Mar 2024. The firm address in the FDA record is in Hampton, NH. FDA put the recall in Class I. FDA event 94169 has 7 product records. The first FDA enforcement report date is 10 Apr 2024. 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.
Worldwide distribution - US Nationwide and the countries of AUSTRIA, BAHRAIN, BRAZIL, COLOMBIA, COSTA RICA, ECUADOR, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, INDIA, IRAQ,…
Recalling firm
SleepNet Corporation, Hampton, NH.
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-1351-2024 | Mojo Full Face with Headgear, All Sizes | 23,042 units | Class I | Ongoing | 10 Apr 2024 |
| Z-1352-2024 | Mojo Non Vented Full Face Mask with Headgear, All Sizes | 11,874 units | Class I | Ongoing | 10 Apr 2024 |
| Z-1353-2024 | Mojo 2 Full Face Vented Mask, All Sizes | 2,787 units | Class I | Ongoing | 10 Apr 2024 |
| Z-1354-2024 | Mojo 2 Full Face Non Vented Mask, All Sizes | 2,107 units | Class I | Ongoing | 10 Apr 2024 |
| Z-1355-2024 | Mojo 2 Full Face AAV Non Vented Mask, All Sizes | 1,268 units | Class I | Ongoing | 10 Apr 2024 |
| Z-1356-2024 | iQ 2 Nasal Vented Mask | 2477 units | Class I | Ongoing | 10 Apr 2024 |
| Z-1357-2024 | Phantom 2 Nasal Vented Mask | 2417 units | Class I | Ongoing | 10 Apr 2024 |
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 2024
- 970
- Share of these events in Class I
- 11%
- Product records in this event
- 7
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1351-2024The 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.
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Cite this page
Recall Register. FDA enforcement event 94169. https://recallregister.com/fda/i/94169/. 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:
Worldwide distribution - US Nationwide and the countries of AUSTRIA, BAHRAIN, BRAZIL, COLOMBIA, COSTA RICA, ECUADOR, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GREECE, INDIA, IRAQ,…
- What quantity of product is in FDA event 94169?
- The event has 7 product records. The first record gives this quantity:
23,042 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 11% of the 970 device events that started in 2024 are in Class I.