FDAClass IIJune 6, 2018

Respire Pink Series EF+ Oral Sleep Apnea Device recall

Respire Pink Series EF+ Oral Sleep Apnea Device.

Why was Respire Pink Series EF+ Oral Sleep Apnea Device recalled?

Potential for device breakage during use

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Number: 50837

Product
Respire Pink Series EF+ Oral Sleep Apnea Device.
Recalling firm
Respire Medical
Quantity
1 unit
Distribution
US nationwide distribution.
Recall date
June 6, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls