Brooklyn, NY, United States
Respire Medical recalls
1 recall recorded since 2018, most recently on 1 September 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 September 2017
- Terminated
- 9 December 2019
- Reason
- Potential for device breakage during use
- Distribution
- US nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1947-2018, Z-1950-2018, Z-1951-2018, Z-1948-2018, Z-1949-2018
- Respire Pink Series EF+ Oral Sleep Apnea Device.
- Respire Pink H/S Oral Sleep Apnea Device
- Respire Pink H/S Oral Sleep Apnea Device
- Respire Pink+ Hard/Soft Oral Sleep Apnea Device
- Respire Pink+ Hard Oral Sleep Apnea Device
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.