FDA Device recall Z-1948-2018
Respire Pink+ Hard/Soft 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/Soft 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-1948-2018 |
| 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/Soft Oral Sleep Apnea Device
Reason
Potential for device breakage during use
Identifiers
| code_info | Serial Numbers: 51366, 51439, 51368, 51577, 51303, 52409, 51985, 51796, 51709, 51744, 51560, 51321, 51545, 51437, 51571…Serial Numbers: 51366, 51439, 51368, 51577, 51303, 52409, 51985, 51796, 51709, 51744, 51560, 51321, 51545, 51437, 51571, 51576, 51438, 51566, 51509, 51629, 51502, 51409, 51307, 51218, 51154, 51001, 51220, 51153 & 50807 |
|---|
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-1948-2018%22
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