SleepNet Corporation: Medical Device Recall in 2024 - (Recall #: Z-1356-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

iQ 2 Nasal Vented Mask

Product Classification:

Class I

Date Initiated: March 1, 2024

Date Posted: April 10, 2024

Recall Number: Z-1356-2024

Event ID: 94169

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2477 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated