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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94169

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 01, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
SleepNet Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

Mojo Full Face with Headgear, All Sizes

Z-1351-2024
Recall number
Z-1351-2024
Initiated
March 01, 2024
Classification
Class I
Status
Ongoing
Recalling firm
SleepNet Corporation
Quantity
23,042 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Update to contraindications and warning language due to CPAP masks containing magnets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Update to contraindications and warning language due to CPAP masks containing magnets.

Code information

All UDI-DI; All Lot Numbers.

Distribution pattern

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.

device · product 2 of 7

Mojo Non Vented Full Face Mask with Headgear, All Sizes

Z-1352-2024
Recall number
Z-1352-2024
Initiated
March 01, 2024
Classification
Class I
Status
Ongoing
Recalling firm
SleepNet Corporation
Quantity
11,874 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Update to contraindications and warning language due to CPAP masks containing magnets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Update to contraindications and warning language due to CPAP masks containing magnets.

Code information

All UDI-DI; All Lot Numbers.

Distribution pattern

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.

device · product 3 of 7

Mojo 2 Full Face Vented Mask, All Sizes

Z-1353-2024
Recall number
Z-1353-2024
Initiated
March 01, 2024
Classification
Class I
Status
Ongoing
Recalling firm
SleepNet Corporation
Quantity
2,787 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Update to contraindications and warning language due to CPAP masks containing magnets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Update to contraindications and warning language due to CPAP masks containing magnets.

Code information

All UDI-DI; All Lot Numbers.

Distribution pattern

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.

device · product 4 of 7

Mojo 2 Full Face Non Vented Mask, All Sizes

Z-1354-2024
Recall number
Z-1354-2024
Initiated
March 01, 2024
Classification
Class I
Status
Ongoing
Recalling firm
SleepNet Corporation
Quantity
2,107 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Update to contraindications and warning language due to CPAP masks containing magnets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Update to contraindications and warning language due to CPAP masks containing magnets.

Code information

All UDI-DI; All Lot Numbers.

Distribution pattern

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.

device · product 5 of 7

Mojo 2 Full Face AAV Non Vented Mask, All Sizes

Z-1355-2024
Recall number
Z-1355-2024
Initiated
March 01, 2024
Classification
Class I
Status
Ongoing
Recalling firm
SleepNet Corporation
Quantity
1,268 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Update to contraindications and warning language due to CPAP masks containing magnets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Update to contraindications and warning language due to CPAP masks containing magnets.

Code information

All UDI-DI; All Lot Numbers.

Distribution pattern

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.

device · product 6 of 7

iQ 2 Nasal Vented Mask

Z-1356-2024
Recall number
Z-1356-2024
Initiated
March 01, 2024
Classification
Class I
Status
Ongoing
Recalling firm
SleepNet Corporation
Quantity
2477 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Update to contraindications and warning language due to CPAP masks containing magnets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Update to contraindications and warning language due to CPAP masks containing magnets.

Code information

All UDI-DI; All Lot Numbers.

Distribution pattern

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.

device · product 7 of 7

Phantom 2 Nasal Vented Mask

Z-1357-2024
Recall number
Z-1357-2024
Initiated
March 01, 2024
Classification
Class I
Status
Ongoing
Recalling firm
SleepNet Corporation
Quantity
2417 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Update to contraindications and warning language due to CPAP masks containing magnets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Update to contraindications and warning language due to CPAP masks containing magnets.

Code information

All UDI-DI; All Lot Numbers.

Distribution pattern

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.

Field note

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