Respire Pink H/S Oral Sleep Apnea Device — Class II medical device recall Z-1950-2018
Terminated recall by Respire Medical, reported 2018-06-06, distributed nationwide. Potential for device breakage during use
| Recall number | Z-1950-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Respire Medical, Brooklyn, NY, United States |
| Recall initiated | 2017-09-01 |
| Classified | 2018-05-29 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2019-12-09 |
| Distributed | Nationwide (US) |
| Reason classes | device malfunction |
| Serial numbers | 46299 |
Product
Respire Pink H/S Oral Sleep Apnea Device
Reason for recall
Potential for device breakage during use
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1950-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.