FDA Device recall Z-1950-2018
Respire Pink H/S Oral Sleep Apnea Device
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of Respire Pink H/S Oral Sleep Apnea Device by Respire Medical, citing potential for device breakage during use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1950-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-01 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Respire Medical |
| Distribution | US |
Product
Respire Pink H/S Oral Sleep Apnea Device
Reason
Potential for device breakage during use
Identifiers
| code_info | Serial Number: 46299 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1950-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.