Recall Z-1951-2018— Respire Medical

Name: FDA recall Z-1951-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-01

Class II · Terminated

Class II FDA medical device recall by Respire Medical, initiated 2017-09-01, terminated 2019-12-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Respire Pink H/S Oral Sleep Apnea Device. Reason: Potential for device breakage during use.

Recalling firm: Respire Medical
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Terminated: 2019-12-09
Firm location: Brooklyn, NY, United States

Product description

Respire Pink H/S Oral Sleep Apnea Device

Reason for recall

Potential for device breakage during use

Data sourced from openFDA. This site is unofficial and independent of the FDA.