Z-1353-2024Class I

Mojo 2 Full Face Vented Mask, All Sizes

Name: Z-1353-2024 Mojo 2 Full Face Vented Mask, All Sizes
Creator: SleepNet Corporation
Published: 2024-03-01
License: https://open.fda.gov/license/

SleepNet Corporation / initiated 2024-03-01 / Open, Classified / root cause: design

FDA source

SleepNet Corporation began a recall of Mojo 2 Full Face Vented Mask, All Sizes on 2024-03-01. FDA classified it as Class I and gives the reason as "Update to contraindications and warning language due to CPAP masks containing magnets". 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-1353-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-03-01
Posted: 2024-04-01
Recalling firm: SleepNet Corporation
Product: Mojo 2 Full Face Vented Mask, All Sizes
Product code: BZD Ventilator, Non-Continuous (Respirator)
Reason for recall: Update to contraindications and warning language due to CPAP masks containing magnets.
Root cause tag: design
FDA root cause: Device Design
Action: The firm emailed consignees a notification titled URGENT: MEDICAL DEVICE RECALL, dated 3/1/24. Consignees were instructed to stop using recalled masks if the user or anyone in close physical contact with the mask has an active medical implant or metallic implant that will interact with magnets and contact their mask provider for a replacement mask that does not contain magnets. Consignees that do not have an active medical implant or metallic implant that will interact with magnets do not have to cease use. If a consignee is unsure whether or not to cease use, they should consult with their physician or manufacturer of the implant. Consignees are to continue using masks according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body. Consignees with any questions are to contact Himabindu Koppusetty via email at [email protected] or by phone at 1-800-742-3646x6611 from Monday through from, 8:00 AM to 4:00 PM.
Quantity in commerce: 2,787 units
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, IRELAND, ISRAEL, ISREAL, ITALY, JAPAN, JORDAN, KUWAIT, LEBANON, MALAYSIA, MEXICO, MOROCCO, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SULTANATE OF OMAN, SWEDEN, SWITZERLAND, THE NETHERLANDS, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VIETNAM, YEMEN.
Product codes and lots: All UDI-DI; All Lot Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1353-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1351-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-01
Z-1352-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-01
Z-1353-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-01
Z-1354-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-01
Z-1355-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-01
Z-1356-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-01
Z-1357-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-10	2024-04-01

Product code BZD

K190254Class IIMojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented MaskSleepnet Corporation / cleared 2019-07-05

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)