FDA recall Z-1950-2018
Respire Medical · Class II · device
Product
Respire Pink H/S Oral Sleep Apnea Device
Reason for recall
Potential for device breakage during use
Distribution
US nationwide distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2017-09-01
- Report date
- 2018-06-06
- Termination date
- 2019-12-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Brooklyn, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1950-2018