Respire Medical recalls Respire Pink+ Hard/Soft Oral Sleep Apnea Device
- Recall date
- September 1, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1948-2018
- FDA classification
- Class II
- Brand / firm
- Respire Medical
- Sold / distributed
- US nationwide distribution.
Why it was recalled
Potential for device breakage during use
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Respire Pink+ Hard/Soft Oral Sleep Apnea Device
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