FDA Device recall Z-1949-2018
Respire Pink+ Hard 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+ Hard 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-1949-2018 |
| 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+ Hard Oral Sleep Apnea Device
Reason
Potential for device breakage during use
Identifiers
| code_info | Serial Numbers: 51447, 51460, 51612, 51318, 51320, 51839, 51714, 51909, 51720, 51397, 51498, 51413, 51581, 51479, 51503…Serial Numbers: 51447, 51460, 51612, 51318, 51320, 51839, 51714, 51909, 51720, 51397, 51498, 51413, 51581, 51479, 51503, 51496, 51163, 51084, 50472, 46747, 46125, 46000, 46101, 46268 & 52634 |
|---|
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-1949-2018%22
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