Hampton, NH, United States
SleepNet Corporation recalls
1 recall recorded since 2018, most recently on 1 March 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 1 March 2024
- Reason
- Update to contraindications and warning language due to CPAP masks containing magnets.
- 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, Q
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1355-2024, Z-1356-2024, Z-1354-2024, Z-1352-2024, Z-1353-2024, Z-1357-2024, Z-1351-2024
- Mojo 2 Full Face AAV Non Vented Mask, All Sizes
- iQ 2 Nasal Vented Mask
- Mojo 2 Full Face Non Vented Mask, All Sizes
- Mojo Non Vented Full Face Mask with Headgear, All Sizes
- Mojo 2 Full Face Vented Mask, All Sizes
- Phantom 2 Nasal Vented Mask
- Mojo Full Face with Headgear, All Sizes
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.