Home › Respironics, Inc. › DreamWear
DreamWear
Respironics, Inc. · Model DreamWear Under Nose Mask, S Frame w/Headgear, CN · UDI-DI 00606959048874
BZD
Prescription
10
510(k) clearances
303,210
Adverse events (4,572 deaths)
81
Recalls
118
Facilities
Description
DreamWear Under the Nose Nasal Mask, Small Frame with Headgear, China
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-30 | Philips Respironics, Inc. | Devices may possess a programming error resulting in an incorrect device configuration. |
| 2025-06-30 | Philips Respironics, Inc. | Devices may possess a programming error resulting in an incorrect device configuration. |
| 2025-06-30 | Philips Respironics, Inc. | Devices may possess a programming error resulting in an incorrect device configuration. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
| 2024-03-01 | SleepNet Corporation | Update to contraindications and warning language due to CPAP masks containing magnets. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.