FDA (Devices) recall action 80030
The FDA (Devices) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Potential for device breakage during use
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Respire Medical is recalling the Pink H/S Oral Sleep Apnea Device because it may break during use.
Respire Medical is recalling 29 units of the Pink+ Hard/Soft Oral Sleep Apnea Device due to a potential for device breakage during use.
Respire Medical is recalling the Respire Pink H/S Oral Sleep Apnea Device due to a potential for device breakage during use.
Respire Medical is recalling 25 units of the Pink+ Hard Oral Sleep Apnea Device due to a potential for device breakage during use.
Respire Medical is recalling the Pink Series EF+ Oral Sleep Apnea Device because it may break during use.